Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Genetic Testing in Screening Patients With Metastatic or Unresectable Colon or Rectal Cancer for a COLOMATE Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03765736
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : September 17, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Academic and Community Cancer Research United

Brief 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. Identifying gene mutations may help patients enroll onto target companion trials that target these mutations.

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

Detailed Description:

PRIMARY OBJECTIVES:

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COLOMATE: Colorectal Cancer Liquid Biopsy Screening Protocol for Molecularly Assigned Therapy
Actual Study Start Date : April 22, 2020
Estimated Primary Completion Date : November 12, 2023
Estimated Study Completion Date : November 12, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genetic Testing

Group/Cohort Intervention/treatment
Screening (genetic testing)
Patients submit blood samples for genetic testing.
Other: Genetic Testing
Undergo genetic testing
Other Names:
  • genetic analysis
  • Genetic Examination
  • Genetic Test




Primary Outcome Measures :
  1. Proportion of patients that enroll in the companion trial recommended by the Colorectal Cancer Liquid Biopsy Screening Protocol for Molecularly Assigned Therapy (COLOMATE) committee [ Time Frame: Up to 5 years ]
    This is defined as the total number of patients that enroll in the recommended companion trial divided by the total number of patients who have an actionable genomic profile. Will be presented as a point estimate along with a 95% confidence interval (by Wald asymptotic confidence limit).

  2. The proportion of patients who have an actionable genomic profile [ Time Frame: Up to 5 years ]
    This is defined as the total number of patients who have an actionable genomic profile divided by the total number of patients that are screened on the COLOMATE protocol. Will be presented as a point estimate along with a 95% confidence interval (by Wald asymptotic confidence limit).


Biospecimen Retention:   Samples With DNA
Blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Study Population
Patients with adenocarcinoma of the colon or rectum that is metastatic and/ or unresectable
Criteria

Inclusion Criteria:

  • 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
  • Willing to provide blood sample for screening purposes

    • NOTE: Guardant360 testing completed =< 60 days prior to registration will be accepted.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Arizona
Mayo Clinic in Arizona Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Clinical Trials Referrals Office    855-776-0015      
Principal Investigator: Tanios S. Bekaii-Saab         
United States, California
UC San Diego Moores Cancer Center Not yet recruiting
La Jolla, California, United States, 92093
Contact: ACCRU Operations    507-538-7459    ACCRU@mayo.edu   
Principal Investigator: Shumei Kato         
USC / Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Carryl Du Bois    323-865-3084    Carryl.DuBois@med.usc.edu   
Principal Investigator: Heinz-Josef Lenz         
Cedars Sinai Medical Center Not yet recruiting
Los Angeles, California, United States, 90048
Contact: Karen Kearns    253-831-3423    Karen.Kearns@cshs.org   
Principal Investigator: Jun Gong         
United States, District of Columbia
MedStar Georgetown University Hospital Not yet recruiting
Washington, District of Columbia, United States, 20007
Contact: ACCRU Operations    507-538-7453    ACCRU@mayo.edu   
Principal Investigator: Benjamin A. Weinberg         
United States, Georgia
Emory University Hospital/Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: KJ Lee    404-778-3173    kyungjong.lee@emory.edu   
Principal Investigator: Christina S. Wu         
United States, Illinois
University of Chicago Comprehensive Cancer Center Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: ACCRU Operations    507-538-7458    ACCRU@mayo.edu   
Principal Investigator: Daniel V. Catenacci         
United States, Massachusetts
Dana-Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: ACCRU Operations    507-538-7450    ACCRU@mayo.edu   
Principal Investigator: Kimmie Ng         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referrals Office    855-776-0015      
Principal Investigator: Joleen M. Hubbard         
United States, Missouri
Washington University School of Medicine Not yet recruiting
Saint Louis, Missouri, United States, 63110
Contact: ACCRU Operations    507-538-7462    ACCRU@mayo.edu   
Principal Investigator: Katrina S. Pedersen         
United States, New York
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
Contact: ACCRU Operations    507-538-7457    ACCRU@mayo.edu   
Principal Investigator: Andrea Cercek         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Anthony Amara    919-668-1861    Anthony.amara@duke.edu   
Principal Investigator: John H. Strickler         
United States, Pennsylvania
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Karen Derzic    412-330-6263    Karen.derzic@ahn.org   
Principal Investigator: Gene G. Finley         
United States, Tennessee
Vanderbilt University/Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Kristen Ciombor    800-811-8480      
Principal Investigator: Kristen K. Ciombor         
United States, Texas
M D Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: ACCRU Operations    507-538-7456    ACCRU@mayo.edu   
Principal Investigator: Benny Johnson         
United States, Wisconsin
Aurora Cancer Care-Milwaukee Not yet recruiting
Milwaukee, Wisconsin, United States, 53209
Contact: ACCRU Operations    507-538-7449    ACCRU@mayo.edu   
Principal Investigator: Federico Augusto H. Sanchez         
Sponsors and Collaborators
Academic and Community Cancer Research United
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: John H Strickler Academic and Community Cancer Research United
Layout table for additonal information
Responsible Party: Academic and Community Cancer Research United
ClinicalTrials.gov Identifier: NCT03765736    
Other Study ID Numbers: ACCRU-GI-1611
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: September 17, 2020
Last Verified: July 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Adenocarcinoma
Rectal Neoplasms
Colonic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases