Genomic Profiling Assay in Phase I



Status:Active, not recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:8/26/2018
Start Date:July 2012
End Date:July 2019

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A Study Exploring the Use of the Foundation Medicine Genomic Profiling Assay in a Phase I Solid Tumor Patient Population

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.

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.

Inclusion Criteria

1. Patients with advanced cancer.

2. Consent for use of archival tissue from primary or metastatic cancer diagnosis. Note:
Patients may currently be enrolled in other investigational protocol including
treatment protocols.

3. Control Group #2 only: Control Group #2 will consist of 100 patients from MDACC/Phase
I historical archives. Patients (cases no older than 2 years) will be selected based
on clinical characteristics and genomic alterations similar to matched targeted
therapy group.

4. Patients may have received prior 'matched' therapies; however, at the time of
enrollment, patients may not currently be on a known 'matched' therapy, and may not
have received a 'matched' therapy as the last treatment if not receiving treatment at
the time of consent.

5. Patients who have a life expectancy of greater than 3 months.

Exclusion Criteria:

1. Patients with advanced cancer who are NOT likely to meet the additional enrollment
criteria in matched targeted therapy protocols or treatments.

2. Patients who do not have archival tissue available.

3. Patients are excluded if their last treatment before enrollment included a targeted
agent matched to a genomic alteration in the patient's tumor.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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