NCT07479381

Colorectal Lesion Evaluation and Appropriate Resolution (CLEAR) Study

Pilot Study to Evaluate a Blood Based Test to Prioritize Diagnostic Colonoscopy Following a Positive Colorectal Cancer Screening Test (CLEAR Study)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 14 (actual)
• Sponsor: Harbinger Health · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate a blood-based screening test for Colorectal Cancer (CRC).

Detailed description

Participants 45 years and older who are at average risk for colorectal cancer (CRC) with a positive multitarget stool DNA (mt-sDNA) screening test result and scheduled to undergo diagnostic colonoscopy as part of standard clinical care within 60 days of providing informed consent (Cohort 1), and participants with confirmed CRC diagnosed within 90 days prior to providing informed consent, based on standard diagnostic procedures (Cohort 2), will be enrolled. Participants enrolled with confirmed CRC must be treatment-naïve at the time of enrollment. A one-time blood sample will be collected from all enrolled participants within 14 days of signing the informed consent form. Participation will be completed when the participant completes the blood draw, and after the participant's cancer status is established (at enrollment for those enrolled with confirmed CRC (Cohort 2), and by 60 days post-colonoscopy for those in the prospective cohort (Cohort 1)). Participants in Cohort 1 may be directly contacted after enrollment if diagnosis details are not available in the medical records. It is expected that study enrollment will take approximately 12 months. Results generated from study samples are investigational and will not be returned to investigators, study participants, or participants' healthcare providers, and will not be used for clinical decision-making.

Conditions

• Colorectal Cancer (Diagnosis)

Timeline

• Start date: 2026-03-20
• Primary completion: 2026-03-27
• Completion: 2026-03-27
• First posted: 2026-03-18
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States