Genetic Testing in Screening Patients With Metastatic or Unresectable Colon or Rectal Cancer for a COLOMATE Trial
NCT ID: NCT03765736
Last Updated: 2025-08-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
199 participants
OBSERVATIONAL
2020-04-20
2023-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Family Communications After Genetic Testing
NCT07143487
Genetic Study of Familial Factors in Patients With Colon Cancer
NCT00055848
Gene Testing in Patients With Colon Cancer
NCT00003571
Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract Cancers
NCT02503631
Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies
NCT01260168
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
I. To perform blood-based genomic profiling on patients with treatment refractory metastatic colorectal cancer (CRC) to facilitate accrual to molecularly assigned therapies.
II. To facilitate clinically annotated genomic analyses.
OUTLINE:
Patients submit blood samples for genetic testing.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Screening (genetic testing)
Patients submit blood samples for genetic testing.
Genetic Testing
Undergo genetic testing
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Genetic Testing
Undergo genetic testing
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Progression, intolerance, or contraindication to a fluoropyrimidine (e.g., 5- fluorouracil or capecitabine), oxaliplatin, irinotecan, an anti-VEGF monoclonal antibody (bevacizumab, ziv-aflibercept, or ramucirumab), and an anti-PD-1 monoclonal antibody (nivolumab or pembrolizumab) if tumor has deficient mismatch repair proteins (dMMR) or is microsatellite instability-high (MSI-H)
* For patients with KRAS and NRAS wild-type tumors, progression, intolerance, or contraindication to an anti-EGFR monoclonal antibody (cetuximab or panitumumab)
* Note: If tissue is known to be positive for HER2 expression (IHC 3+) or the tumor has ERBB2 (HER2) amplification detected by a Clinical Laboratory Improvement Act (CLIA)-certified assay, prior treatment with anti-EGFR therapy is not required
* At least one site of disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1) that has not been previously irradiated; if the patient has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
* Life expectancy \>= 3 months per estimation of investigator
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
* Capable of understanding and complying with the protocol requirements and has signed the informed consent document
* Satisfy at least one of the following two conditions:
* Willing and able to provide blood sample for screening purposes
* Guardant 360 testing completed =\< 60 days prior to registration
Exclusion Criteria
* Unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee
* History of solid organ transplantation
* Pregnant or planning to become pregnant within the next 12 months
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Academic and Community Cancer Research United
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John H Strickler
Role: PRINCIPAL_INVESTIGATOR
Academic and Community Cancer Research United
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
M D Anderson Cancer Center
Houston, Texas, United States
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2018-02862
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACCRU-GI-1611
Identifier Type: OTHER
Identifier Source: secondary_id
ACCRU-GI-1611
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.