Clinical trial NCT01772771: Molecular Testing for the MD Anderson Cancer Center Personalized Cancer Therapy Program
Official title: Molecular Testing for the MD Anderson Cancer Center Personalized Cancer Therapy Program
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glioma
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Melanoma
Sarcoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-01-21
Enrollment: 12000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with histologically, radiographic, or cytologically documented cancer, suspected glioma, sarcoma, melanoma or hematologic cancer

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.

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 and other biomarkers detectable in plasma, exosomes or blood and their predictive value and 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.

VI. To determine feasibility of identifying novel antigens and other targets for novel strategies such as vaccines, immunotherapy and cell surface therapy

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Frequency of mutations and co-mutations
timeFrame: 20 years
measure: Distributions of mutations (including on gene expressions)
timeFrame: 20 years
measure: Database of somatic mutations and clinical characteristics
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
measure: Circulating cell free deoxyribonucleic acid (cfDNA) analysis
timeFrame: 20 years
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Funda Meric-Bernstam
role: PRINCIPAL_INVESTIGATOR
References: