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BRIEF TITLE: Molecular Testing for the MD Anderson Cancer Center Personalized Cancer Therapy Program

Molecular Testing for the MD Anderson Cancer Center Personalized Cancer Therapy Program


  • Org Study ID: PA11-0852
  • Secondary ID:
  • NCT ID: NCT01772771
  • NCT Alias:
  • Sponsor: M.D. Anderson Cancer Center - Other
  • Source: M.D. Anderson Cancer Center

Brief Summary

The main goal of this study is to perform standardized testing of tumor tissue to learn which genes are mutated (have changed) to provide personalized cancer therapy options to patients at MD Anderson. Your doctor may be able to use testing information on your tumor to identify clinical trials that may be most relevant to you. Another goal of this laboratory research study is to learn how often different genes mutate in patients with different cancers. Researchers will also use the information learned from this study to develop a database of the different kinds of mutations in cancer-related genes. Researchers also hope to better understand how mutations in cancer-related genes may affect a patient's response to different therapies. Researchers can use this information to select specific therapies for future patients that are more likely to be effective.

Detailed Description


If you agree to take part in this study, information about your disease and your previous and
future treatments and outcomes will be recorded from your medical records. A sample of your
tumor tissue that was already collected and stored at MD Anderson or another institution will
be collected.

If your tumor tissue is stored at another institution, a company called eHealth Global that
specializes in picking up and delivering this kind of tissue, may be used to collect and
deliver your samples to MD Anderson. If eHealth Global is used, they may have access to
certain identifiable health information, which will include the accession number of your
tissue sample, your demographic information (to know where to pick up the sample), and your
Medical Record Number (used to label the sample so that the laboratory knows that it is for
your tests). eHealth Global will not keep this information and it will only be used to move
your samples from the outside institution to MD Anderson.

Your medical record information will be entered into a password-protected database that can
only be accessed by authorized members of the research staff and your treating physician at
MD Anderson.

The tissue sample will be tested to look for mutations in cancer-related genes and for
protein testing. Any leftover DNA will be stored in a research bank at MD Anderson for future
research related to this study.

Before your samples can be used for research outside of this study, the people doing the
research must get specific approval from the Institutional Review Board (IRB) of MD Anderson.
The IRB is a committee made up of doctors, researchers, and members of the community. The IRB
is responsible for protecting the participants involved in research studies and making sure
all research is done in a safe and ethical manner. All research done at MD Anderson,
including research involving your samples from this bank, must first be approved by the IRB.

Your samples will be given a code number. Researchers in the laboratory will not have
identifying information directly linked to your samples. However, the researchers in charge
of this study and their team members, as well as your oncologist will be able to link the
samples to you. This is to allow medical data related to the samples to be updated as needed.
Other researchers using your samples will not be able to link this data to you.

Some of your sample material may be sent to institutions outside of MD Anderson for advanced
testing.

Some of your samples may be sent to outside institutions or companies (such as Guardant
Health Inc.) for clinical laboratory improvements amendments (CLIA)-verified advanced
testing. A CLIA-certified lab has to meet certain standards for all lab testing to ensure
accuracy, reliability, and timeliness of patient test results regardless of where the test is
performed. Your name and a sample identifier, along with information about your sample and
disease that are necessary to complete the testing will be provided along with your sample.
The information from the CLIA-certified tests done at outside companies or institutions will
become part of your medical record.

If your sample is sent to outside institutions for standard research testing only, no
identifying information about you will be included with the sample. Results from standard
research tests from outside companies or institutions will not be included in your medical
record and you will not receive information about the results of these tests.

Length of Study:

Your active participation will be over after you sign this consent form and your tissue and
blood samples have been collected. You medical records may continue to be reviewed for up to
20 years.

This is an investigational study.

Up to 8,000 patients will take part in this study. All will be enrolled at MD Anderson.

Overal Status Start Date Phase Study Type
Recruiting Start Date: March 2012 N/A Observational

Primary Outcomes:

Primary Outcome 1 - Measure: Database of Somatic Mutations and Clinical Characteristics

Primary Outcome 1 - Time Frame: 20 years

Condition:

  • Invasive Cancer
  • Sarcoma
  • Hematologic Cancer

Eligibility

Criteria:
Inclusion Criteria:

1. Patients must have histologically, radiographic, or cytologically documented cancer,
suspected glioma, sarcoma, melanoma or hematologic cancer. Patients with benign tumors
may also be consented at the discretion of the attending physician if molecular
profiling is felt to have potential clinical implications.

2. Patients must have the ability to understand and the willingness to sign a written
informed consent document.

3. Patients may be consented without confirming the amount and quality of archival
diagnostic or residual tissue available. However, research testing will only be
performed on patients who have sufficient archived diagnostic tissue or residual
tissue banked in one of the authorized tissue banks at MD Anderson available to
proceed with testing. The extent of testing may be modified based on amount of tissue
available. If any new tissue acquisition including a biopsy and/or surgical resection
etc. is being ordered for clinical care or another research study, or an operation is
being performed testing can be ordered on that sample.

4. cfDNA Cohort: Circulating cell-free DNA next generation sequencing (NGS) testing will
be performed with the CLIA-certified Guardant360 panel (or equivalent) for select
patients. This particular cohort of research collaboration will be supported by
Guardant Health, Inc. at no charge to MD Anderson. Patients who are being considered
for enrollment into clinical trials in the next 2 lines of therapy may be enrolled.

Exclusion Criteria:
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Gender: All

Minimum Age: N/A

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: Funda Meric-Bernstam, MD

Role: Study Chair

Affiliation: M.D. Anderson Cancer Center

Overall Contact

Name: Funda Meric-Bernstam, MD

Phone: 713-792-6940

Email:

Link: The University of Texas MD Anderson Cancer Center Official Website

Location

Facility Status Contact
University of Texas MD Anderson Cancer Center/Regional Cancer Centers
Houston, Texas 77030
United States
Recruiting