Molecular Testing for the MD Anderson Cancer Center Personalized Cancer Therapy Program
2 other identifiers
observational
12,000
1 country
1
Brief Summary
This study performs standardized testing of tumor tissue samples to learn which genes are mutated (have changed) in order to provide personalized cancer therapy options to cancer patients at MD Anderson. This may help doctors use testing information on tumors to identify clinical trials that may be most relevant to patients. Researchers may also use the information learned from this study to develop a database of the different kinds of mutations in cancer-related genes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 14, 2013
CompletedFirst Posted
Study publicly available on registry
January 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2033
March 3, 2026
February 1, 2026
20 years
January 14, 2013
February 27, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Frequency of mutations and co-mutations
Will be assessed with descriptive statistics along with 95% Wilson score confidence intervals.
20 years
Distributions of mutations (including on gene expressions)
Distributions of mutations (including on gene expressions) between different tumor types and levels of clinical-pathological factors will be compared using the chi-squared test or Fisher's exact test, as appropriate for categorical variables
20 years
Database of somatic mutations and clinical characteristics
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.
20 years
Other Outcomes (1)
Circulating cell free deoxyribonucleic acid (cfDNA) analysis
20 years
Study Arms (1)
Ancillary-correlative (biospecimen collection, chart review)
Patients' previously collected tissue samples are analyzed. Patients may also undergo collection of blood, saliva or buccal samples for analysis. Patients' medical records are reviewed.
Interventions
Undergo collection of blood, saliva/buccal swab samples
Correlative studies
Review of medical records
Eligibility Criteria
Patients with histologically, radiographic, or cytologically documented cancer, suspected glioma, sarcoma, melanoma or hematologic cancer
You may qualify if:
- 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.
- Patients must have the ability to understand and the willingness to sign a written informed consent document
- 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
- Circulating cell-free deoxyribonucleic acid (cfDNA) Cohort: Circulating cell-free DNA next generation sequencing (NGS) testing will be performed with the Clinical Laboratory Improvement Act (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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
Biospecimen
Tissue, blood, saliva/buccal swabs
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Funda Meric-Bernstam
M.D. Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2013
First Posted
January 21, 2013
Study Start
March 1, 2012
Primary Completion (Estimated)
March 1, 2032
Study Completion (Estimated)
March 1, 2033
Last Updated
March 3, 2026
Record last verified: 2026-02