Neoplasm
Conditions
Keywords
Cancer Genetics
Brief summary
The primary objective of this specimen correlative study is two-fold: to provide a mechanism for the association of known molecular alterations with clinical outcomes, and to provide rapid genetic profiling of alterations with known clinical utility using tumor and germline specimens to support treatment decisions.
Interventions
DIAGNOSTIC_TESTTumor Genetic Sequencing
This study will look at genetic material from a sample of the subjects tumor, look at certain changes in the genetic material, and see if these changes are related to the subjects cancer.
Sponsors
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Current or prospective cancer patients; current cancer patients must have histologically or cytologically confirmed diagnosis of cancer 2. Tumor tissue available and suitable for molecular analyses from at least one of the following sources: * Tissue previously stored in UNC's Tissue Procurement Facility (TPF) * Tissue previous stored at an institution other than UNC-CH, provided investigators can determine that the tumors were sampled and stored under appropriate conditions for inclusion in the study * Patient undergoing tissue collection as per clinical standard of care and willing to allow specimens from surplus tissue to be diverted for research purposes * Patient undergoing tissue collection as per clinical standard of care and willing to have additional specimens taken for research * Patient willing to undergo biopsy for purpose of research only 3. The following inclusion criteria apply only to patients undergoing biopsy for research purposes only under this protocol: * ≥18 years of age * Treatment options offer no expectation of cure, e.g., advanced solid tumor patients with metastatic disease. NOTE: This restriction applies to biopsy of vital organs only, e.g., lung, liver, etc. * Appropriate candidate for research biopsy based on institutional standards for target biopsy site
Exclusion criteria
1. Any condition that would make participation in the protocol unreasonably hazardous for the patient in the opinion of the treating physician 2. Dementia, altered mental status, or any psychiatric condition or co-morbid condition that would prohibit the understanding or rendering of informed consent. 3. The following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With a Reportable Genetic Variant | 1 year | To estimate the proportion of patients enrolled on the study who have undergone successful sequencing and have a reportable genetic variant identified |
| Progression Free Survival | 2 Year | Estimate Progression Free Survival (PFS) at 2 years in cancer patients with active disease with a reportable genetic variant and those without a reportable genetic variant |
Other
| Measure | Time frame | Description |
|---|---|---|
| Collect and Describe Clinical Data | 1 Year | To collect and describe clinical data including treatment outcomes after availability of results in patients |
| Progression Free Survival | 1 Year | To compare progression free survival ratios between cancer patients with active disease with reportable genetic variant who were treated based on variant and those who were not treated based on a variant |
Countries
United States
Participant flow
Pre-assignment details
Of the 2798 participants screened for eligibility, 2074 were deemed eligible, 459 failed processing/sequencing, 226 had a sample collection failure, 19 were pediatric patients who were excluded from the final cohort, and 20 consents were withdrawn.
Participants by arm
| Arm | Count |
|---|---|
| Sequencing Arm All eligible subjects who had Tumor Genetic Sequencing performed. This sequencing looked at genetic material from a sample of the subjects tumor and certain changes in the genetic material, to see if these changes are related to the subjects cancer. | 2,074 |
| Total | 2,074 |
Baseline characteristics
| Characteristic | Sequencing Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 592 Participants |
| Age, Categorical Between 18 and 65 years | 1482 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 67 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1972 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 35 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 13 Participants |
| Race (NIH/OMB) Asian | 31 Participants |
| Race (NIH/OMB) Black or African American | 327 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 125 Participants |
| Race (NIH/OMB) White | 1573 Participants |
| Region of Enrollment United States | 2074 participants |
| Sex: Female, Male Female | 1352 Participants |
| Sex: Female, Male Male | 722 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 723 / 2,074 |
| other Total, other adverse events | 0 / 2,074 |
| serious Total, serious adverse events | 0 / 2,074 |
Outcome results
Primary
Progression Free Survival
Estimate Progression Free Survival (PFS) at 2 years in cancer patients with active disease with a reportable genetic variant and those without a reportable genetic variant
Time frame: 2 Year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sequencing Arm | Progression Free Survival | 31 percentage of participants |
| Not Reported | Progression Free Survival | 62 percentage of participants |
Primary
Proportion of Patients With a Reportable Genetic Variant
To estimate the proportion of patients enrolled on the study who have undergone successful sequencing and have a reportable genetic variant identified
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sequencing Arm | Proportion of Patients With a Reportable Genetic Variant | 0.61 proportion of participants |
Other Pre-specified
Collect and Describe Clinical Data
To collect and describe clinical data including treatment outcomes after availability of results in patients
Time frame: 1 Year
Other Pre-specified
Progression Free Survival
To compare progression free survival ratios between cancer patients with active disease with reportable genetic variant who were treated based on variant and those who were not treated based on a variant
Time frame: 1 Year