Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequencing Arm | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor Genetic Sequencing | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| 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 | 2 Year |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Collect and Describe Clinical Data | To collect and describe clinical data including treatment outcomes after availability of results in patients | 1 Year |
| 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 |
Inclusion Criteria:
Current or prospective cancer patients; current cancer patients must have histologically or cytologically confirmed diagnosis of cancer
Tumor tissue available and suitable for molecular analyses from at least one of the following sources:
The following inclusion criteria apply only to patients undergoing biopsy for research purposes only under this protocol:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| H. Shelton Earp, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | 95% Confidence Interval | proportion of participants | 1 year |
|
|
One year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robin Johnson | UNC Lineberger Comprehensive Cancer Center | 919-966-1125 | robin_v_johnson@med.unc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2019 | Oct 1, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 Year |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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 | Posted | Number | 95% Confidence Interval | percentage of participants | 2 Year |
|
|
|
| Other Pre-specified | Collect and Describe Clinical Data | To collect and describe clinical data including treatment outcomes after availability of results in patients | Not Posted | 1 Year | Participants |
| 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 | Not Posted | 1 Year | Participants |
| 723 |
| 2,074 |
| 0 |
| 2,074 |
| 0 |
| 2,074 |
Not provided