Protocol to Validate the Performance of the LifeKit® Prevent Colorectal Neoplasia Test for CRC Screening

NCT04693546 | Suspended

• 1 other identifier: PM-2020-001
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Colorectal Adenoma

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity for the LifeKit Prevent Colorectal Neoplasia Test for adenoma, including advanced adenoma

  Through study completion, an average of 180 days

Secondary Outcomes (4)

• Sensitivity and specificity of the LifeKit Prevent Colorectal Neoplasia Test for colorectal cancer

  Through study completion, an average of 180 days

• Sensitivity and specificity of the LifeKit Prevent Colorectal Neoplasia Test for advanced adenoma

  Through study completion, an average of 180 days

• Sensitivity of the LifeKit Prevent Colorectal Neoplasia Test is non-inferior to that of FIT for colorectal cancer

  Through study completion, an average of 180 days

• Sensitivity of the LifeKit Prevent Colorectal Neoplasia Test is superior to that of FIT for advanced adenoma

  Through study completion, an average of 180 days

Interventions

LifeKit Prevent Colorectal Neoplasia Test DIAGNOSTIC_TEST

Procedure: Colonoscopy

FIT Test DIAGNOSTIC_TEST

Procedure: Colonoscopy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects 40 years of age and older who are eligible for colorectal cancer screening and scheduled for a screening colonoscopy per standard of care. Approximately 12,000 subjects will be targeted for enrollment.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Metabiomics Corp: lead

Study Sites (1)

Solvd Health

Carlsbad, California, 92008, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: January 5, 2021
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

US (1)