Metastatic Colon AdenocarcinomaNCT03765736
Genetic Testing in Screening Patients With Metastatic or Unresectable Colon or Rectal Cancer for a COLOMATE Trial
An observational study of Metastatic Colon Adenocarcinoma and Metastatic Rectal Adenocarcinoma, run by Academic and Community Cancer Research United at 18 sites in United States.
Trial summary
This trial screens patients with colon or rectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable) for genetic mutations for recommendation to a molecularly assigned therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colon Adenocarcinoma, Metastatic Rectal Adenocarcinoma, Stage III Colon Cancer AJCC v8
- What is being tested?
- Genetic Testing
- How many people
- 199 participants
- Where
- 18 sitesUnited States
- Study dates
- 20 Apr 2020to 1 Dec 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with adenocarcinoma of the colon or rectum that is metastatic and/ or unresectable
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Duke University Medical Center
Durham, North Carolina, 27710
M D Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
UC San Diego Moores Cancer Center
La Jolla, California, 92093
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Cedars Sinai Medical Center
Los Angeles, California, 90048
Aurora Cancer Care-Milwaukee
Milwaukee, Wisconsin, 53209
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Washington University School of Medicine
St Louis, Missouri, 63110
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
Official title: COLOMATE: Colorectal Cancer Liquid Biopsy Screening Protocol for Molecularly Assigned Therapy
This trial screens patients with colon or rectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable) for genetic mutations for recommendation to a molecularly assigned therapy. Identifying gene mutations may help patients enroll onto target companion trials that target these mutations.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- 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
- Being tested
- Genetic Testing
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic TestingOther
Also called genetic analysis, Genetic Examination, Genetic Test
Undergo genetic testing
| Study group | Role | What they receive |
|---|---|---|
| Screening (genetic testing) | Patients submit blood samples for genetic testing. Receives: Other: Genetic Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Patients Who Have an Actionable Genomic Profile
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).
Measured: 6 months
Companion Trial Enrollment
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).
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start20 Apr 2020
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Colon AdenocarcinomaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academic and Community Cancer Research United
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- John H Strickler, Principal investigator, Academic and Community Cancer Research United
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765736
- Sponsor's protocol ID
- ACCRU-GI-1611
- Other IDs
- NCI-2018-02862, ACCRU-GI-1611, P30CA015083
- Status last verified
- Aug 2025
- First submitted
- 4 Dec 2018
- Last updated
- 29 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COLOMATE: Colorectal Cancer Liquid Biopsy Screening Protocol for Molecularly Assigned Therapy
- ClinicalTrials.gov ID
- NCT03765736
- Acronym / sponsor ID
- ACCRU-GI-1611
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Academic and Community Cancer Research UnitedUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 5 Dec 2018 (actual)
- Results
- Posted 23 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial screens patients with colon or rectal cancer that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable) for genetic mutations for recommendation to a molecularly assigned therapy. Identifying gene mutations may help patients enroll onto target companion trials that target these mutations.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening (genetic testing) | – | Other: Genetic TestingPatients submit blood samples for genetic testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with adenocarcinoma of the colon or rectum that is metastatic and/ or unresectable
Key inclusion criteria (11 listed)
- 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)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic TestingAlso: genetic analysis, Genetic Examination, Genetic TestUndergo genetic testing | Other | Screening (genetic testing) |
Primary outcome
The Proportion of Patients Who Have an Actionable Genomic Profile
Time frame: 6 months
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: 3.5 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John H Strickler principal investigator
Academic and Community Cancer Research United
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colon Adenocarcinoma and Metastatic Rectal Adenocarcinoma, run by Academic and Community Cancer Research United at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Proportion of Patients Who Have an Actionable Genomic Profile (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.