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

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.

Study Overview

• Status: Recruiting
• Conditions: Glioma; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm; Melanoma; Sarcoma
• Intervention / Treatment: Procedure: Biospecimen Collection; Other: Genetic Testing; Other: Medical Chart Review

Detailed Description

PRIMARY OBJECTIVES:

I. To perform standardized molecular analysis for patients at MD Anderson to assist in personalized cancer therapy.

II. To determine the frequency of mutations and co-mutations and other alterations in cancer-related genes in different tumor types.

III. To establish a database of somatic mutations, copy number alterations, gene fusion/translocation information and other biomarker alterations and clinical characteristics that can be used to select patients that may be eligible for new targeted therapy trials.

SECONDARY OBJECTIVES:

I. To determine enrollment to pathway-targeted therapy trials by cancer genotype and ribonucleic acid (RNA) and protein expression, and plan additional pathway-targeted therapy trials.

II. To determine how somatic and germline mutations in cancer-related genes, other molecular alterations affect response to commonly used anti-tumor therapies and cancer outcomes.

III. To determine genomic alterations detectable in plasma and their evolution with treatment.

IV. To perform multiplex and non-multiplex protein and protein/RNA screening using different platforms such as immunohistochemistry (IHC), immunofluorescence, (IF) mass spectrometry (MS), and nanostring of slides or tissue microarrays.

V. To determine feasibility of identifying actionable targets and rationale drug combinations based on gene expression profiling and systems biology.

OUTLINE:

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.

• Study Type: Observational
• Enrollment (Estimated): 12000

Contacts and Locations

• Study Contact: Name: Funda Meric-Bernstam, MD; Phone Number: 713-792-6940; Email: fmeric@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Funda Meric-Bernstam; Phone Number: 713-792-6940
      • Principal Investigator: Funda Meric-Bernstam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically, radiographic, or cytologically documented cancer, suspected glioma, sarcoma, melanoma or hematologic cancer

Description

Inclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Biospecimen Collection; Undergo collection of blood, saliva/buccal swab samples; Other: Genetic Testing; Correlative studies; Other Names: genetic analysis; Genetic Examination; Genetic Test; Other: Medical Chart Review; Review of medical records; Other Names: Chart Review

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circulating cell free deoxyribonucleic acid (cfDNA) analysis	cfDNA analysis will be performed as an exploratory study to determine the concordance of specific alterations in the plasma and in tumor analysis, and to determine the change in cfDNA burden and mutation profile with treatment.	20 years

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Funda Meric-Bernstam, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• The University of Texas MD Anderson Cancer Center Official Website

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2012
• Primary Completion (Estimated): March 1, 2032
• Study Completion (Estimated): March 1, 2033

Study Registration Dates

• First Submitted: January 14, 2013
• First Submitted That Met QC Criteria: January 17, 2013
• First Posted (Estimated): January 21, 2013

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: PA11-0852 (Other Identifier: M D Anderson Cancer Center); NCI-2020-07334 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No