Personalized Cancer Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01772771
First received: January 14, 2013
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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.


Condition
Invasive Cancer
Sarcoma
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)
Groups/Cohorts
Cancer Patients
Patients with histologically or cytologically documented invasive cancer, sarcoma, or hematologic cancer

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals diagnosed with cancer.

Criteria

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 a new biopsy is being ordered for clinical care or another research study, or an operation is being performed testing can be ordered on that sample.

Exclusion Criteria:

N/A

  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 ClinicalTrials.gov identifier: NCT01772771

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

Locations
United States, Texas
UT MDACC/Regional Cancer Centers Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Funda Meric-Bernstam, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Funda Meric-Bernstam, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01772771     History of Changes
Other Study ID Numbers: PA11-0852
Study First Received: January 14, 2013
Last Updated: July 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Cancer
Molecular testing
Personalized Cancer Therapy Program
Bladder
Bone
Breast
Cytology
Endocrine
Gynecology
Endocrine - Neoplasia
genitourinary
Research Biorepository
Head and Neck
Aerodigestive Tract
Hematopathology
Human Cancer Genetics
Kidney
Leukemia
Lower Gastrointestinal
Lymphoma
Melanoma
Neurology
Brain
Non-Melanoma Skin
Pancreas
Pediatrics
Prostate
Breast Cancer Patients, Serum
Plasma
Soft Tissue Sarcoma

Additional relevant MeSH terms:
Hematologic Neoplasms
Sarcoma
Hematologic Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on October 23, 2014