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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 : Not yet recruiting
First Posted : December 5, 2018
Last Update Posted : April 15, 2019
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 or cannot be removed by surgery 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
Colon Adenocarcinoma Rectal Adenocarcinoma 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 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 obtain tumor tissue and patient-matched tumor deoxyribonucleic acid (DNA) from peripheral blood to facilitate clinically annotated genomic analyses.

CORRELATIVE RESEARCH OBJECTIVES:

I. To explore mechanisms of acquired resistance to molecularly assigned therapy.

II. To explore the correlation between circulating cell free tumor DNA (cfDNA) mutational burden (allele frequency, copy number) and clinical outcomes (overall response rate [ORR], progression free survival [PFS], overall survival [OS]).

OUTLINE:

Patients submit blood samples for genetic testing.


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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
Estimated Study Start Date : December 31, 2019
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

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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
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

Exclusion Criteria:

  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator would interfere with conduct of the study or study results
  • Evidence within the last 3 years of another malignancy which required systemic treatment. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix
  • Unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee

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


Sponsors and Collaborators
Academic and Community Cancer Research United
National Cancer Institute (NCI)
Investigators
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Principal Investigator: John H Strickler Academic and Community Cancer Research United

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Responsible Party: Academic and Community Cancer Research United
ClinicalTrials.gov Identifier: NCT03765736     History of Changes
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: April 15, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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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