Melanoma
Conditions
Brief summary
This study will collect real-world data from advanced melanoma diagnosis through most recent visit and data sourced from patient medical records following a 2-part study design consisting of a random sample (Part 1) and an oversample (Part 2).
Interventions
OTHERNon-Interventional
Non-Interventional
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults 18 years or older * Diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma before 01-Nov-2015 * Initiating a new line of therapy during the index period between 01-Jan-2015 and 31-May-2016, irrespective of advanced melanoma diagnosis date * Medical history available for medical chart abstraction from date of diagnosis through most recent or current therapy (defined as end of data collection period)
Exclusion criteria
* Physicians unwilling or unable to follow study instructions * Patients who were previously enrolled in a cancer treatment-related clinical trial since the diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of treatment patterns for advanced melanoma patients | Aproximately 6 months | Distribution of treatment patterns for advanced melanoma patients including, treatment regimen selection and rationale, as well as time to initiation of therapy and type of therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of Patient Age at index date | at baseline | Patient Age at index date will be determined from Medical Records |
| Distribution of Patient's Sex at Index Date | At Baseline | Patient's sex will be determined from Medical Records |
| Distribution of Comorbidities at index date | At Baseline | Comorbidities will be determined using the Charlson Comorbidity Index (CCI) |
| Distribution of Healthcare Coverage type | At Baseline | Healthcare Coverage type will be determined using Medical Records |
| Distribution of Diagnosis Date | At Baseline | Melanoma Diagnosis Date will be determined using medical records |
| Distribution of Advanced Diagnosis Date | At Baseline | Date of advanced/ metastatic melanoma diagnosis will be determined using medical records |
| Distribution of Age at Onset | At Baseline | Diagnosis date-Date of Birth |
| Distribution of Disease stage at time of diagnosis | At Baseline | Disease stage at time of diagnosis will be determined using medical records |
| Distribution of Disease stage at subsequent visits | Approximately 16 months | Disease stage at subsequent visits will be determined using medical records |
| Distribution of prescribing patterns | Approximately 16 months | Distribution of prescribing patterns by type of practice setting and melanoma patient volume |
| Distribution of ECOG status at Last Visit | Approximately 16 months | Eastern Cooperative Oncology Group (ECOG) status at Last Visit will be determined using medical records |
| Distribution of Biomarker status at baseline | at baseline | Biomarker status will be determined using Medical Records |
| Distribution of treatment-related adverse events | Approximately 16 months | treatment-related adverse events will be determined using medical records |
| Distribution of Overall Survival (OS) from Advanced Diagnosis | Approximately 16 months | Date of death minus advanced/metastatic diagnosis date, censoring for LTF or end of observation |
| Distribution of Progression-Free Survival (PFS) at Advanced Diagnosis | Approximately 16 months | Date of progression (increase in tumor size or increase in cancer stage)/start of next line of therapy minus advanced/metastatic diagnosis date, censoring for LTF or end of observation |
| Distribution of Overall Response Rate (ORR) | Approximately 16 months | — |
| Distribution of Overall Survival (OS) from Index Date | Approximately 16 months | Date of death minus index treatment start date, censoring for LTF or end of observation |
| Distribution of Progression-Free Survival (PFS) at Index Date | Approximately 16 months | Date of progression (increase in tumor size or increase in cancer stage)/start of next line of therapy minus index treatment start date, censoring for LTF or end of observation |
| Distribution of melanoma related HCRU | Approximately 16 months | — |
| Distribution of ECOG status at Baseline | At Baseline | Eastern Cooperative Oncology Group (ECOG) status at Baseline will be determined using medical records |
Countries
United States
Outcome results
None listed