Genetic Testing in Screening Patients With Metastatic or Unresectable Colon or Rectal Cancer for a COLOMATE Trial
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|ClinicalTrials.gov Identifier: NCT03765736|
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : May 11, 2023
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|Condition or disease||Intervention/treatment|
|Metastatic Colon Adenocarcinoma Metastatic Rectal Adenocarcinoma Stage III Colon Cancer AJCC v8 Stage III Rectal Cancer AJCC v8 Stage IIIA Colon Cancer AJCC v8 Stage IIIA Rectal Cancer AJCC v8 Stage IIIB Colon Cancer AJCC v8 Stage IIIB Rectal Cancer AJCC v8 Stage IIIC Colon Cancer AJCC v8 Stage IIIC Rectal Cancer AJCC v8 Stage IV Colon Cancer AJCC v8 Stage IV Rectal Cancer AJCC v8 Stage IVA Colon Cancer AJCC v8 Stage IVA Rectal Cancer AJCC v8 Stage IVB Colon Cancer AJCC v8 Stage IVB Rectal Cancer AJCC v8 Stage IVC Colon Cancer AJCC v8 Stage IVC Rectal Cancer AJCC v8 Unresectable Colon Adenocarcinoma Unresectable Rectal Adenocarcinoma||Other: Genetic Testing|
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.
Patients submit blood samples for genetic testing.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||COLOMATE: Colorectal Cancer Liquid Biopsy Screening Protocol for Molecularly Assigned Therapy|
|Actual Study Start Date :||April 20, 2020|
|Estimated Primary Completion Date :||November 11, 2023|
|Estimated Study Completion Date :||November 12, 2025|
Screening (genetic testing)
Patients submit blood samples for genetic testing.
Other: Genetic Testing
Undergo genetic testing
- The proportion of patients who have an actionable genomic profile [ Time Frame: Up to 5 years ]This is defined as a patient who received a trial recommendation per the COLOMATE companion trial recommendation form. Will be presented as a point estimate along with a 95% confidence interval (by Wald asymptotic confidence limit).
- Companion trial enrollment [ Time Frame: Up to 5 years ]This is defined as a patient who has an actionable genomic profile that enrolls in their recommended companion trial. Will be presented as a point estimate along with a 95% confidence interval (by Wald asymptotic confidence limit).
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Histological confirmation of adenocarcinoma of the colon or rectum that is metastatic and/ or unresectable
- 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
- Evidence within the last 3 years of another malignancy which required systemic treatment. EXCEPTIONS: Non-melanotic skin cancer, carcinoma-in-situ of the cervix, or localized prostate cancer with a current PSA of < 1.0mg/dL on 2 successive evaluations, at least 90 days apart, with the most recent evaluation no more than 4 weeks prior to registration
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03765736
|Principal Investigator:||John H Strickler||Academic and Community Cancer Research United|
|Responsible Party:||Academic and Community Cancer Research United|
|Other Study ID Numbers:||
NCI-2018-02862 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ACCRU-GI-1611 ( Other Identifier: Academic and Community Cancer Research United )
P30CA015083 ( U.S. NIH Grant/Contract )
|First Posted:||December 5, 2018 Key Record Dates|
|Last Update Posted:||May 11, 2023|
|Last Verified:||May 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases