Sample Collection Study for the CellMax Life Circulating Tumor Cell and Circulating Tumor DNA Platforms for the Early Detection of Colorectal Cancer and Adenomas

CellMax Life15 sites in 1 country1,000 target enrollmentDecember 15, 2020

ConditionsColorectal Cancer Screening

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Colorectal Cancer Screening
Sponsor: CellMax Life
Enrollment: 1000
Locations: 15
Primary Endpoint: Sensitivity for CRC of the FirstSight test
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to collect clinical specimens from subjects with a diagnosis of colorectal cancer/advanced adenoma or undergoing a screening colonoscopy and meeting study eligibility criteria.

Registry

clinicaltrials.gov

Start Date

December 15, 2020

End Date

December 30, 2022

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

CellMax Life

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•To enroll in Cohort A, a subject must:
•Be 45-80 years of age (inclusive) at the time of screening.
•Be recently diagnosed with primary colorectal cancer or advanced adenoma with plans to surgically remove the target lesion.
•To enroll in Cohort B, a subject must:
•Be 45-80 years of age (inclusive) at the time of screening.
•Be planning to undergo a screening colonoscopy within 30 days after providing signed informed consent.

Exclusion Criteria

•To enroll in Cohort A, a subject must NOT have:
•Inflammatory bowel disease (IBD)
•Personal or family history of colorectal cancer syndromes or other hereditary cancer syndromes
•To enroll in Cohort B, a subject must NOT have:
•Personal history of colorectal cancer, colorectal adenoma or aerodigestive tract cancer.
•Personal or family history of Familial adenomatous polyposis (FAP).
•Personal or family history of Hereditary non-polyposis colorectal cancer syndrome (HNPCC or Lynch Syndrome).
•Positive fecal occult blood testing (FOBT) within the previous 6 months.
•Positive fecal immunochemical testing (FIT) in the previous 6 months.
•Colorectal resection for any reason other than sigmoid diverticular disease.