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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

None

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood, saliva/buccal swab samples

  • Genetic Testing

    Other intervention

    Correlative studies

  • Medical Chart Review

    Other intervention

    Review of medical records

Treatment groups

12,000 Participants
are divided into 1 treatment group
Group A: Ancillary-correlative (biospecimen collection, chart review)3 interventions

Trial outcomes

Primary outcomes

1

Frequency of mutations and co-mutations

Will be assessed with descriptive statistics along with 95% Wilson score confidence intervals.

Time frame
20 years
2

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

Time frame
20 years
3

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.

Time frame
20 years

Secondary outcomes

Other outcomes

1

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.

Time frame
20 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator