Trials / Completed
CompletedNCT02437617
Genomic Profiling Assay in Phase I
A Study Exploring the Use of the Foundation Medicine Genomic Profiling Assay in a Phase I Solid Tumor Patient Population
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (actual)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The goal of this research study is to collect and test tumor tissue from patients with advanced cancers that may be enrolled in Phase 1 studies or other treatments. Researchers will study if the results from genetic testing can help researchers determine which therapy may prove more beneficial for a patient in the future.
Detailed description
If you agree to take part in this study, your tumor tissue collected previously from surgery or a prior biopsy (archived tissue) will be used for genetic testing. Genetic testing looks at whether specific genes are changed (mutated) in the tumor. The results of the genetic testing will be documented in your medical record. Your doctor may use the results of the genetic testing to help decide which treatment you will have. While awaiting results of the genomic profile assay, you may be enrolled in another treatment either at MD Anderson or near your home. This will be decided by your treating physician. Your samples will be given a code number when they are sent for genetic testing to Foundation Medicine. No identifying information will be directly linked to your samples. Only the researcher in charge of sending all tissue for testing will have access to the code numbers and be able to link the samples to you. This is to allow medical data related to the samples to be updated as needed. Foundation Medicine will not be able to link this data to you. Researchers will also review your medical history from before and following the collection of tissue, to learn if the use of genetic testing had any effect on the outcome of your treatment. This is an investigational study. Up to 300 participants will take part in this study. All will be enrolled at MD Anderson.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Tumor Tissue | Tumor tissue collected previously from surgery or a prior biopsy (archived tissue) used for genetic testing. |
Timeline
- Start date
- 2012-07-13
- Primary completion
- 2021-06-01
- Completion
- 2021-06-01
- First posted
- 2015-05-07
- Last updated
- 2021-06-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02437617. Inclusion in this directory is not an endorsement.