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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01772771
Recruitment Status : Recruiting
First Posted : January 21, 2013
Last Update Posted : May 14, 2019
The Once Upon a Time Foundation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.

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.

This is an investigational study.

Up to 12,000 patients will take part in this study. All will be enrolled at MD Anderson.

Condition or disease
Invasive Cancer Sarcoma Hematologic Cancer

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Study Type : Observational
Estimated Enrollment : 12000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Molecular Testing for the MD Anderson Cancer Center Personalized Cancer Therapy Program
Actual Study Start Date : March 2012
Estimated Primary Completion Date : March 2032
Estimated Study Completion Date : March 2033

Resource links provided by the National Library of Medicine

Cancer Patients
Patients with histologically or cytologically documented invasive cancer, sarcoma, or hematologic cancer

Primary Outcome Measures :
  1. Database of Somatic Mutations and Clinical Characteristics [ Time Frame: 20 years ]
    Collection and storage of tumor tissue specimens, blood and/or saliva samples of patients with cancer for somatic mutation analysis for assessing patients that may be eligible for new targeted therapy trials.

Biospecimen Retention:   Samples With DNA
Blood drawn once during a scheduled visit. Buccal swab or saliva sample may be collected during a scheduled visit for patients with hematologic or other disease.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals diagnosed with cancer.

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. Selected patients may have cfDNA, circulating RNA /exosome/Circulating tumor cell testing approaches performed on alternate platforms (eg Foundation ACT).

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01772771

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Contact: Funda Meric-Bernstam, MD 713-792-6940

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United States, Texas
University of Texas MD Anderson Cancer Center/Regional Cancer Centers Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Funda Meric-Bernstam, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
The Once Upon a Time Foundation
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Study Chair: Funda Meric-Bernstam, MD M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01772771    
Other Study ID Numbers: PA11-0852
First Posted: January 21, 2013    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Keywords provided by M.D. Anderson Cancer Center:
Molecular testing
Personalized Cancer Therapy Program
Endocrine - Neoplasia
Research Biorepository
Head and Neck
Aerodigestive Tract
Human Cancer Genetics
Lower Gastrointestinal
Non-Melanoma Skin
Breast Cancer Patients, Serum
Soft Tissue Sarcoma
Additional relevant MeSH terms:
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Hematologic Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms by Site
Hematologic Diseases