Personalized Cancer Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: January 14, 2013
Last updated: August 21, 2015
Last verified: August 2015

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.

Invasive Cancer
Hematologic Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Molecular Testing for the MD Anderson Cancer Center Personalized Cancer Therapy Program

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Database of Somatic Mutations and Clinical Characteristics [ Time Frame: 20 years ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 8000
Study Start Date: March 2012
Estimated Primary Completion Date: March 2032 (Final data collection date for primary outcome measure)
Cancer Patients
Patients with histologically or cytologically documented invasive cancer, sarcoma, or hematologic cancer

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Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals diagnosed with cancer.

Inclusion Criteria:

  1. Patients must have histologically or cytologically documented invasive 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 68 gene 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 with adequate performance status (PS 0-1) who have active metastatic or inoperable locally advanced cancer or solid tumors and are being considered for enrollment into clinical trials in the next 2 lines of therapy will be enrolled. Additionally, patients whose original solid tumor block has been exhausted, deemed insufficient for testing by the Molecular Diagnostics Laboratory or is otherwise unavailable for testing may be enrolled.

Exclusion Criteria:

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01772771

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

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
Study Chair: Funda Meric-Bernstam, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center Identifier: NCT01772771     History of Changes
Other Study ID Numbers: PA11-0852
Study First Received: January 14, 2013
Last Updated: August 21, 2015
Health Authority: United States: Institutional Review Board

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:
Hematologic Neoplasms
Hematologic Diseases
Neoplasms by Site processed this record on December 01, 2015