NCT04693546

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

Subject Enrollment and Specimen Collection Protocol to Validate the Performance of the LifeKit® Prevent Colorectal Neoplasia Test for Colorectal Cancer Screening

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 12,000 (estimated)
• Sponsor: Metabiomics Corp · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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 a central laboratory and that will be tested using a commercially available FIT. After sample collection, subjects will undergo a screening colonoscopy per standard of care. Investigators will be blinded to the results of the LifeKit Prevent Colorectal Neoplasia Test during the study; the LifeKit Prevent Colorectal Neoplasia Test and FIT results will not be used for clinical management of subjects. Personnel performing the colonoscopy and reports from the colonoscopy and personnel performing the histopathological review of the tissue and/or any reports will remain blinded to the results of the LifeKit Prevent Colorectal Neoplasia Test results.

Conditions

• Colorectal Cancer
• Colorectal Adenoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	LifeKit Prevent Colorectal Neoplasia Test	Procedure: Colonoscopy
DIAGNOSTIC_TEST	FIT Test	Procedure: Colonoscopy

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-12-01
• Completion: 2028-03-01
• First posted: 2021-01-05
• Last updated: 2025-09-26

Locations

1 site across 1 country: United States