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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01772771
• Other study ID #: PA11-0852
• Secondary ID: NCI-2020-07334PA
• Status: Recruiting
• Start date: March 1, 2012
• Est. completion date: March 1, 2033

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: Funda Meric-Bernstam, MD
• Phone: 713-792-6940
• Email: fmeric[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12000
• Est. completion date: March 1, 2033
• Est. primary completion date: March 1, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Glioma
• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm
• Melanoma
• Neoplasms
• Sarcoma

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood, saliva/buccal swab samples

Other:
• Genetic Testing
Correlative studies
• Medical Chart Review
Review of medical records

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Frequency of mutations and co-mutations	Will be assessed with descriptive statistics along with 95% Wilson score confidence intervals.	20 years
Primary	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
Primary	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

External Links

•   The University of Texas MD Anderson Cancer Center Official Website