GliomaNCT01772771
Molecular Testing for the MD Anderson Cancer Center Personalized Cancer Therapy Program
An observational study of Glioma and Hematopoietic and Lymphoid Cell Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glioma, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Biospecimen Collection, Genetic Testing and Medical Chart Review
- Type of treatment
- Surgery or procedure
- How many people
- 12,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2012to 1 Mar 2033
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with histologically, radiographic, or cytologically documented cancer, suspected glioma, sarcoma, melanoma or hematologic cancer
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Funda Meric-Bernstam, 713-792-6940
Funda Meric-Bernstam
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To perform molecular analysis for patients at MD Anderson to assist in personalized cancer therapy.
II. To determine the frequency of mutations, co-mutations and, other alterations including germline polymorphism and deleterious mutations (germline genetic factors), in cancer-related genes within different tumor types, and to determine patient preference for return of results.
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:
- To determine enrollment to pathway-targeted therapy trials by cancer genotype and RNA and protein expression and plan additional pathway-targeted therapy trials.
II. To determine how somatic and/or germline mutations (including polymorphisms) in cancer-related genes, and other molecular alterations affect response to anti-tumor therapies and cancer outcomes and to determine how germline polymorphisms affect toxicity and side effects with cancer therapy.
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 protein and RNA screening using different platforms such as immunohistochemistry (IHC), multiplex IHC, immunofluorescence (IF), mass spectrometry (MS), and Nanostring including assays from slides or tissue microarrays and image analysis strategies including digital pathology.
- 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.
VII. To use integrated biomarker and clinical data in conjunction with novel computational tools including large language models, machine learning, and other artificial intelligence tools for biomarker discovery and therapy-matching.
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.
- Conditions
- Glioma, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Melanoma, Sarcoma
- Being tested
- Biospecimen Collection, Genetic Testing, Medical Chart Review
- Medical subject headings
- Glioma, Hematologic Neoplasms, Melanoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen CollectionProcedure or surgery
Undergo collection of blood, saliva/buccal swab samples
Genetic TestingOther
Also called genetic analysis, Genetic Examination, Genetic Test
Correlative studies
Medical Chart ReviewOther
Also called Chart Review
Review of medical records
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Biospecimen Collection; Other: Genetic Testing; Other: Medical Chart Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of mutations and co-mutations
Will be assessed with descriptive statistics along with 95% Wilson score confidence intervals.
Measured: 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
Measured: 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.
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study start1 Mar 2012
- Primary completion1 Mar 2032 (estimated)
- Study completion1 Mar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Funda Meric-Bernstam, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772771
- Sponsor's protocol ID
- PA11-0852
- Other IDs
- NCI-2020-07334, PA11-0852
- Status last verified
- Aug 2026
- First submitted
- 14 Jan 2013
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No