Status:
SUSPENDED
Protocol to Validate the Performance of the LifeKit® Prevent Colorectal Neoplasia Test for CRC Screening
Lead Sponsor:
Metabiomics Corp
Conditions:
Colorectal Cancer
Colorectal Adenoma
Eligibility:
All Genders
40+ years
Brief Summary
The purpose of this study is to determine the sensitivity and specificity for LifeKit Prevent Colorectal Neoplasia Test for colorectal cancer (CRC) and for adenoma, including advanced adenoma.
Detailed Description
Subjects 40 years of age and older scheduled for a screening colonoscopy will be enrolled. Subjects will collect a stool sample that will be tested by the LifeKit Prevent Colorectal Neoplasia Test at ...
Eligibility Criteria
Inclusion
- An individual must meet all of the criteria below to be eligible.
- Subject is ≥ 40 years of age at the time of enrollment.
- Subject presents for a screening colonoscopy per standard of care.
- Subject has no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
- Subject is able and willing to sign informed consent.
Exclusion
- An individual meeting any of the below criteria is ineligible.
- Subject has a history of CRC or advanced precancerous lesions.
- Subject has a diagnosis or medical history of any of the following conditions:
- Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome)
- Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome")
- Other hereditary cancer syndromes, including but are not limited to, Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis
- Subject has a diagnosis or personal history of inflammatory bowel disease (IBD), including chronic ulcerative colitis or Crohn's disease.
- Subject has a diagnosis of Cronkhite-Canada Syndrome.
- Subject has had a positive Cologuard, fecal occult blood test or FIT within the previous 2 years.
- Subject has undergone a colonoscopy within the previous 9 years.
- Subject has had overt rectal bleeding within the previous 30 days.
- Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
Key Trial Info
Start Date :
March 1 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
12000 Patients enrolled
Trial Details
Trial ID
NCT04693546
Start Date
March 1 2026
End Date
March 1 2028
Last Update
September 26 2025
Active Locations (1)
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1
Solvd Health
Carlsbad, California, United States, 92008