Prevention of Colorectal Cancer Through Multiomics Blood Testing

Completed

• Conditions: Rectal Cancer; Colon Lesion; Adenoma; Colon Diseases; Colorectal Cancer; Rectal Diseases; Gastrointestinal Tract Cancers; Colon Neoplasm; Polyp; Colon Cancer

• Registration Number: NCT04369053
• Lead Sponsor: Freenome Holdings Inc.

Brief Summary

The PREEMPT CRC study is a prospective multi-center observational study to validate a blood-based test for the early detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.

Detailed Description

Freenome is using a type of artificial intelligence, called machine learning, to identify patterns of cell-free biomarkers in blood to detect cancer early. The purpose of this prospective multi-center observational study is to validate a blood-based test for the detection of colorectal cancer by collecting blood samples from average-risk participants who will undergo a routine screening colonoscopy.

Study Timeline

• Study First Submitted: 2020-04-27
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-30
• Study Start: 2020-05-20
• Primary Completion: 2024-02-29
• Study Completion: 2024-02-29
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48995

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity for CRC of the Freenome test	90 days
Specificity of the Freenome test	90 days

Trial Locations

Locations (195)

Gastroenterology Associates of New Jersey(2); 🇺🇸 Wayne, New Jersey, United States

Gastroenterology Associates of New Jersey(8); 🇺🇸 Wayne, New Jersey, United States

Pinnacle Research Group LLC; 🇺🇸 Anniston, Alabama, United States

Birmingham VA Medical Center - Alabama; 🇺🇸 Birmingham, Alabama, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Birmingham Gastroenterology Associates; 🇺🇸 Homewood, Alabama, United States

Advanced Gastroenterology PC; 🇺🇸 Chandler, Arizona, United States

Southeast Valley Gastro (SEVG); 🇺🇸 Chandler, Arizona, United States

Hope Research Institute; 🇺🇸 Phoenix, Arizona, United States

Premier Gastroenterology Associates-Arkansas; 🇺🇸 Little Rock, Arkansas, United States

Scroll for more (185 remaining)