Renal Cell Carcinoma
Conditions
Brief summary
This study aims at estimating the proportion of patients diagnosed with locoregional renal cell carcinoma who are at high risk for recurrence following nephrectomy, describe referral patterns, and characterize treatment in this population. Outcomes including estimation of the incidence of recurrence and disease-free interval following nephrectomy will be reported overall and among the subgroup off patients receiving adjuvant systemic therapy with sunitinib following nephrectomy.
Interventions
PROCEDUREnephrectomy
Surgery performed within the study period
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must meet all of the following inclusion criteria to be eligible for data abstraction: * Diagnosed with locoregional RCC (no distant metastasis at the time of diagnosis) * Underwent a nephrectomy at Duke between 01 April 2014, and 31 December 2019 (final dates determined based on results from part 2 data collection) * Aged 18 years or older at nephrectomy
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time From Nephrectomy to Recurrence: Modified High Risk Sub-group | From nephrectomy up to disease recurrence, approximately during 5 years (data observed during 9 months of retrospective study) | Time from nephrectomy to recurrence (in months) was defined as the time from nephrectomy to the high risk of RCC recurrence or end of participant record or receipt of systemic therapy or death due to any cause. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. |
| Follow-up Duration | From index date to the last entry in the medical record, death, or disease recurrence, approximately during 5 years (data observed during 9 months of retrospective study) | Follow- up time (in years) was duration between index date to the last entry in the medical record, death, or disease recurrence. The date of nephrectomy was considered as index date. |
| Number of Participants Classified According to Follow-up Plan Determined at First Post-operative Visit | At first post-nephrectomy visit during approximately during 5 years (data observed during 9 months of retrospective study) | In this outcome measure number of participants were classified according to their follow-up plan determined at first post-operative visit. Follow-up plans were as follows: 1) surveillance, 2) adjuvant systemic therapy (AST), 3) follow-up plan not recorded in the medical record and 4) other. |
| Number of Participants With Transfer of Care to a Non-Duke Provider | At first post-nephrectomy visit during approximately during 5 years (data observed during 9 months of retrospective study) | In this outcome measure number of participants with transfer of care to a non-Duke provider were reported. |
| Number of Participants With no Documented Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group | Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study) | Among number of participants who were followed up for any referral, those participants who had no documented oncologic/RCC related care referrals were recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. |
| Number of Participants Classified According to Type of Referring Provider for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group | Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study) | Number of participants according to the type of provider who referred for oncologic or RCC related care after nephrectomy were recorded and reported. Type of providers included urologist, primary care, and other. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. |
| Number of Participants Classified According to Type of Provider Referred to for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group | Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study) | Number of participants according to the type of provider referred to, for oncologic/RCC related care after nephrectomy were recorded and reported. Type of providers to whom participants were referred included medical oncologist, radiation oncologist, urologist, interventional radiologist, and medical geneticist. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. |
| Number of Participants Classified According to Reasons for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group | Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study) | Number of participants according to reasons for being referred to oncologic or RCC related care after nephrectomy were recorded and reported. Reasons included discussion of adjuvant systemic therapy (AST) options, other discussion of management options, and other. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. |
| Time to Any Referral for Oncologic/Renal Cell Carcinoma (RCC) Related Care: Modified High Risk Sub-group | Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study) | After nephrectomy, time (in days) to any referral for oncologic or RCC related care was recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. |
| Time From Nephrectomy to Subsequent Surgery: Modified High Risk Sub-group | From nephrectomy up to the subsequent surgery, approximately during 5 years (data observed during 9 months of retrospective study) | Time from nephrectomy (in months) up to the subsequent surgery was recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. |
| Number of Participants Classified According to Type of Subsequent Surgery: Modified High Risk Sub-group | From nephrectomy up to the subsequent surgery, approximately during 5 years (data observed during 9 months of retrospective study) | Number of participants according to the type of subsequent surgery after nephrectomy were reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. |
| Time From Nephrectomy to Receipt of First-line Adjuvant Systemic Therapy (AST): Modified High Risk Sub-group | From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study) | Time from nephrectomy up to the first-line AST was recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. |
| Number of Participants Classified According to Type of Systemic Agents Received as First-line AST: Modified High Risk Sub-group | From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study) | Number of participants according to type of systemic agents received as first-line AST were recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. |
| Mean of Starting Dose of First-line AST Received: Modified High Risk Sub-group | From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study) | Mean of starting dose of first-line AST received after nephrectomy was reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. |
| Number of Participants Who Were Treated With First-line AST as Part of a Clinical Trial in the Adjuvant Setting: Modified High Risk Sub-group | From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study) | In this outcome measure number of participants who were treated with first-line AST after nephrectomy as a part of clinical trial in adjuvant setting were reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. |
| Number of Participants Classified According to First-line AST Discontinuation Reasons: Modified High Risk Sub-group | From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study) | In this outcome measure number of participants were classified according to reason for discontinuation of treatment with first-line AST after nephrectomy. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. |
| RCC Related Follow-up Duration After Nephrectomy: Modified High Risk Sub-group | From nephrectomy up to the follow-up, approximately during 5 years (data observed during 9 months of retrospective study) | RCC related follow-up duration after nephrectomy was reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. |
| Number of Participants Who Died: Modified High Risk Sub-group | From nephrectomy up to death by any cause, approximately during 5 years (data observed during 9 months of retrospective study) | Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. |
| Number of Participants Classified According to Type of Disease Recurrence: Modified High Risk Sub-group | From nephrectomy up to disease recurrence, approximately during 5 years (data observed during 9 months of retrospective study) | Number of participants according to the type of disease recurrence are reported. Type of disease recurrence were locoregional and distant. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Disease Free Survival (DFS): Modified High Risk Sub-group | From nephrectomy up to earliest documentation of high-risk of recurrence or death, approximately during 5 years (data observed during 9 months of retrospective study) | DFS was defined as the time interval (in months) from date of nephrectomy to earliest documentation of high-risk of RCC recurrence or death. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group. |
Countries
United States
Participant flow
Recruitment details
Medical record data, for participants with locoregional renal cell carcinoma (RCC), who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019, were compiled retrospectively by Duke researchers via an institutional database.
Pre-assignment details
Data collected were observed and evaluated in this study's duration of approximately 9 months.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Eligible participants diagnosed with locoregional RCC who were recommended to go through nephrectomy at Duke from 01 April 2014 to 31 December 2019 were included and their data from medical records were evaluated and observed in the study. | 618 |
| Total | 618 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 61.67 years STANDARD_DEVIATION 11.15 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 0 | 132 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 1 | 129 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 2 | 8 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 3 | 0 Participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status 4 | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 154 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 460 Participants |
| Mean Tumor Size | 5.27 centimeter STANDARD_DEVIATION 3.39 |
| Number of Participants Classified According to Clear Cell Predominance No | 161 Participants |
| Number of Participants Classified According to Clear Cell Predominance Yes | 457 Participants |
| Number of Participants Classified According to Nephrectomy Year 2014 | 0 Participants |
| Number of Participants Classified According to Nephrectomy Year 2015 | 80 Participants |
| Number of Participants Classified According to Nephrectomy Year 2016 | 131 Participants |
| Number of Participants Classified According to Nephrectomy Year 2017 | 120 Participants |
| Number of Participants Classified According to Nephrectomy Year 2018 | 128 Participants |
| Number of Participants Classified According to Nephrectomy Year 2019 | 159 Participants |
| Number of Participants Classified According to Tumor Fuhrman (Nuclear) Grade Grade 1 | 71 Participants |
| Number of Participants Classified According to Tumor Fuhrman (Nuclear) Grade Grade 2 | 401 Participants |
| Number of Participants Classified According to Tumor Fuhrman (Nuclear) Grade Grade 3 | 95 Participants |
| Number of Participants Classified According to Tumor Fuhrman (Nuclear) Grade Grade 4 | 28 Participants |
| Number of Participants Classified According to Tumor Necrosis Absent | 458 Participants |
| Number of Participants Classified According to Tumor Necrosis Present | 156 Participants |
| Number of Participants Classified According to Tumor, Node, Metastasis (TNM) stage Stage 1 | 420 Participants |
| Number of Participants Classified According to Tumor, Node, Metastasis (TNM) stage Stage 2 | 65 Participants |
| Number of Participants Classified According to Tumor, Node, Metastasis (TNM) stage Stage 3 | 133 Participants |
| Number of Participants Classified According to Tumor, Node, Metastasis (TNM) stage Stage 4 | 0 Participants |
| Number of Participants Classified According to Type of Nephrectomy Full | 295 Participants |
| Number of Participants Classified According to Type of Nephrectomy Partial | 323 Participants |
| Race/Ethnicity, Customized Race Black | 57 Participants |
| Race/Ethnicity, Customized Race Missing | 458 Participants |
| Race/Ethnicity, Customized Race White | 103 Participants |
| Sex/Gender, Customized Female | 200 Participants |
| Sex/Gender, Customized Male | 417 Participants |
| Sex/Gender, Customized Other | 1 Participants |
| Time from RCC Diagnosis to Nephrectomy | 5.03 days STANDARD_DEVIATION 69.5 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Follow-up Duration
Follow- up time (in years) was duration between index date to the last entry in the medical record, death, or disease recurrence. The date of nephrectomy was considered as index date.
Time frame: From index date to the last entry in the medical record, death, or disease recurrence, approximately during 5 years (data observed during 9 months of retrospective study)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and studied.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants | Follow-up Duration | 1.07 years |
Primary
Mean of Starting Dose of First-line AST Received: Modified High Risk Sub-group
Mean of starting dose of first-line AST received after nephrectomy was reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Time frame: From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study)
Population: Analysis population included participants who were at modified high risk of recurrence. Here Overall Number of Participants Analyzed signifies participants who received first-line AST after nephrectomy and were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Mean of Starting Dose of First-line AST Received: Modified High Risk Sub-group | 125.00 milligram | Standard Deviation 106.07 |
Primary
Number of Participants Classified According to First-line AST Discontinuation Reasons: Modified High Risk Sub-group
In this outcome measure number of participants were classified according to reason for discontinuation of treatment with first-line AST after nephrectomy. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Time frame: From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study)
Population: Analysis population included participants who were at modified high risk of recurrence. Here Overall Number of Participants Analyzed signifies participants who received first-line AST after nephrectomy and were evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Classified According to First-line AST Discontinuation Reasons: Modified High Risk Sub-group | Adverse Event | 1 Participants |
| All Participants | Number of Participants Classified According to First-line AST Discontinuation Reasons: Modified High Risk Sub-group | Disease Progression | 1 Participants |
Primary
Number of Participants Classified According to Follow-up Plan Determined at First Post-operative Visit
In this outcome measure number of participants were classified according to their follow-up plan determined at first post-operative visit. Follow-up plans were as follows: 1) surveillance, 2) adjuvant systemic therapy (AST), 3) follow-up plan not recorded in the medical record and 4) other.
Time frame: At first post-nephrectomy visit during approximately during 5 years (data observed during 9 months of retrospective study)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and studied. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Classified According to Follow-up Plan Determined at First Post-operative Visit | Surveillance | 519 Participants |
| All Participants | Number of Participants Classified According to Follow-up Plan Determined at First Post-operative Visit | AST | 25 Participants |
| All Participants | Number of Participants Classified According to Follow-up Plan Determined at First Post-operative Visit | Not Recorded | 5 Participants |
| All Participants | Number of Participants Classified According to Follow-up Plan Determined at First Post-operative Visit | Other | 3 Participants |
Primary
Number of Participants Classified According to Reasons for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group
Number of participants according to reasons for being referred to oncologic or RCC related care after nephrectomy were recorded and reported. Reasons included discussion of adjuvant systemic therapy (AST) options, other discussion of management options, and other. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Time frame: Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)
Population: Analysis population included participants who were at modified high risk of recurrence. Here Overall Number of Participants Analyzed signifies participants who were referred for oncologic/RCC-related care.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Classified According to Reasons for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group | Discussion of AST Options | 25 Participants |
| All Participants | Number of Participants Classified According to Reasons for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group | Other Discussion Management Options | 2 Participants |
| All Participants | Number of Participants Classified According to Reasons for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group | Other | 4 Participants |
Primary
Number of Participants Classified According to Type of Disease Recurrence: Modified High Risk Sub-group
Number of participants according to the type of disease recurrence are reported. Type of disease recurrence were locoregional and distant. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Time frame: From nephrectomy up to disease recurrence, approximately during 5 years (data observed during 9 months of retrospective study)
Population: Analysis population included participants who were at modified high risk of recurrence. Here Overall Number of Participants Analyzed signifies participants who had RCC recurrence after nephrectomy.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Classified According to Type of Disease Recurrence: Modified High Risk Sub-group | Locoregional | 4 Participants |
| All Participants | Number of Participants Classified According to Type of Disease Recurrence: Modified High Risk Sub-group | Distant | 38 Participants |
Primary
Number of Participants Classified According to Type of Provider Referred to for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group
Number of participants according to the type of provider referred to, for oncologic/RCC related care after nephrectomy were recorded and reported. Type of providers to whom participants were referred included medical oncologist, radiation oncologist, urologist, interventional radiologist, and medical geneticist. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Time frame: Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)
Population: Analysis population included participants who were at modified high risk of recurrence. Here Overall Number of Participants Analyzed signifies participants who were referred for oncologic/RCC-related care.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Classified According to Type of Provider Referred to for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group | Medical Oncologist | 29 Participants |
| All Participants | Number of Participants Classified According to Type of Provider Referred to for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group | Radiation Oncologist | 0 Participants |
| All Participants | Number of Participants Classified According to Type of Provider Referred to for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group | Urologist | 0 Participants |
| All Participants | Number of Participants Classified According to Type of Provider Referred to for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group | Interventional Radiology | 1 Participants |
| All Participants | Number of Participants Classified According to Type of Provider Referred to for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group | Medical Geneticist | 1 Participants |
Primary
Number of Participants Classified According to Type of Referring Provider for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group
Number of participants according to the type of provider who referred for oncologic or RCC related care after nephrectomy were recorded and reported. Type of providers included urologist, primary care, and other. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Time frame: Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)
Population: Analysis population included participants who were at modified high risk of recurrence. Here Overall Number of Participants Analyzed signifies participants who were referred for oncologic/RCC-related care.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Classified According to Type of Referring Provider for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group | Urologist | 31 Participants |
| All Participants | Number of Participants Classified According to Type of Referring Provider for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group | Primary Care | 0 Participants |
| All Participants | Number of Participants Classified According to Type of Referring Provider for Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group | Other | 0 Participants |
Primary
Number of Participants Classified According to Type of Subsequent Surgery: Modified High Risk Sub-group
Number of participants according to the type of subsequent surgery after nephrectomy were reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Time frame: From nephrectomy up to the subsequent surgery, approximately during 5 years (data observed during 9 months of retrospective study)
Population: Analysis population included participants who were at modified high risk of recurrence. Here Overall Number of Participants Analyzed signifies participants who had any subsequent surgery after nephrectomy.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Classified According to Type of Subsequent Surgery: Modified High Risk Sub-group | Radical Nephrectomy | 1 Participants |
| All Participants | Number of Participants Classified According to Type of Subsequent Surgery: Modified High Risk Sub-group | Partial Nephrectomy | 0 Participants |
| All Participants | Number of Participants Classified According to Type of Subsequent Surgery: Modified High Risk Sub-group | Other | 4 Participants |
Primary
Number of Participants Classified According to Type of Systemic Agents Received as First-line AST: Modified High Risk Sub-group
Number of participants according to type of systemic agents received as first-line AST were recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Time frame: From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study)
Population: Analysis population included participants who were at modified high risk of recurrence. Here Overall Number of Participants Analyzed signifies participants who received first-line AST after nephrectomy.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Number of Participants Classified According to Type of Systemic Agents Received as First-line AST: Modified High Risk Sub-group | Clinical Trial - Agent Not Specified | 2 Participants |
| All Participants | Number of Participants Classified According to Type of Systemic Agents Received as First-line AST: Modified High Risk Sub-group | Sunitinib | 1 Participants |
Primary
Number of Participants Who Died: Modified High Risk Sub-group
Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Time frame: From nephrectomy up to death by any cause, approximately during 5 years (data observed during 9 months of retrospective study)
Population: Analysis population included participants who were at modified high risk of recurrence. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants Who Died: Modified High Risk Sub-group | 15 Participants |
Primary
Number of Participants Who Were Treated With First-line AST as Part of a Clinical Trial in the Adjuvant Setting: Modified High Risk Sub-group
In this outcome measure number of participants who were treated with first-line AST after nephrectomy as a part of clinical trial in adjuvant setting were reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Time frame: From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study)
Population: Analysis population included participants who were at modified high risk of recurrence. Here Overall Number of Participants Analyzed signifies participants who received first-line AST after nephrectomy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants Who Were Treated With First-line AST as Part of a Clinical Trial in the Adjuvant Setting: Modified High Risk Sub-group | 2 Participants |
Primary
Number of Participants With no Documented Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group
Among number of participants who were followed up for any referral, those participants who had no documented oncologic/RCC related care referrals were recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Time frame: Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)
Population: Analysis population included participants who were at modified high risk of recurrence. Here 'Overall Number of Participants Analyzed' signifies participants who were followed up for evaluation for any referral.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants With no Documented Oncologic/RCC Related Care Referrals: Modified High Risk Sub-group | 88 Participants |
Primary
Number of Participants With Transfer of Care to a Non-Duke Provider
In this outcome measure number of participants with transfer of care to a non-Duke provider were reported.
Time frame: At first post-nephrectomy visit during approximately during 5 years (data observed during 9 months of retrospective study)
Population: Analysis population included all eligible participants whose data were retrieved from medical records and studied. Here 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | Number of Participants With Transfer of Care to a Non-Duke Provider | 36 Participants |
Primary
RCC Related Follow-up Duration After Nephrectomy: Modified High Risk Sub-group
RCC related follow-up duration after nephrectomy was reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Time frame: From nephrectomy up to the follow-up, approximately during 5 years (data observed during 9 months of retrospective study)
Population: Analysis population included participants who were at modified high risk of recurrence. Here Overall Number of Participants Analyzed signifies participants who were followed up related to RCC after nephrectomy.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants | RCC Related Follow-up Duration After Nephrectomy: Modified High Risk Sub-group | 1.57 years |
Primary
Time From Nephrectomy to Receipt of First-line Adjuvant Systemic Therapy (AST): Modified High Risk Sub-group
Time from nephrectomy up to the first-line AST was recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Time frame: From nephrectomy up to the first-line AST, approximately during 5 years (data observed during 9 months of retrospective study)
Population: Analysis population included participants who were at modified high risk of recurrence. Here Overall Number of Participants Analyzed signifies participants who received first-line AST after nephrectomy.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants | Time From Nephrectomy to Receipt of First-line Adjuvant Systemic Therapy (AST): Modified High Risk Sub-group | 82.00 days |
Primary
Time From Nephrectomy to Recurrence: Modified High Risk Sub-group
Time from nephrectomy to recurrence (in months) was defined as the time from nephrectomy to the high risk of RCC recurrence or end of participant record or receipt of systemic therapy or death due to any cause. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Time frame: From nephrectomy up to disease recurrence, approximately during 5 years (data observed during 9 months of retrospective study)
Population: Analysis population included participants who were at modified high risk of recurrence. Here Overall Number of Participants Analyzed signifies participants who had RCC recurrence after nephrectomy and were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants | Time From Nephrectomy to Recurrence: Modified High Risk Sub-group | 5.72 months |
Primary
Time From Nephrectomy to Subsequent Surgery: Modified High Risk Sub-group
Time from nephrectomy (in months) up to the subsequent surgery was recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Time frame: From nephrectomy up to the subsequent surgery, approximately during 5 years (data observed during 9 months of retrospective study)
Population: Analysis population included participants who were at modified high risk of recurrence. Here Overall Number of Participants Analyzed signifies participants who had any subsequent surgery after nephrectomy.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants | Time From Nephrectomy to Subsequent Surgery: Modified High Risk Sub-group | 11.90 months |
Primary
Time to Any Referral for Oncologic/Renal Cell Carcinoma (RCC) Related Care: Modified High Risk Sub-group
After nephrectomy, time (in days) to any referral for oncologic or RCC related care was recorded and reported. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Time frame: Post-nephrectomy approximately during 5 years (data observed during 9 months of retrospective study)
Population: Analysis population included participants who were at modified high risk of recurrence. Here Overall Number of Participants Analyzed signifies participants who were referred for oncologic/RCC-related care and were evaluable for this outcome measure.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants | Time to Any Referral for Oncologic/Renal Cell Carcinoma (RCC) Related Care: Modified High Risk Sub-group | 50.00 days |
Other Pre-specified
Disease Free Survival (DFS): Modified High Risk Sub-group
DFS was defined as the time interval (in months) from date of nephrectomy to earliest documentation of high-risk of RCC recurrence or death. Data for this outcome measure was planned to be collected and analyzed in modified high risk sub-group.
Time frame: From nephrectomy up to earliest documentation of high-risk of recurrence or death, approximately during 5 years (data observed during 9 months of retrospective study)
Population: Analysis population included participants who were at modified high risk of recurrence.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants | Disease Free Survival (DFS): Modified High Risk Sub-group | NA months |