Circulating Tumor DNA in Patients Summoned for Colonoscopy; - a Liquid Biopsy for Detection, Characterization, Individualized Treatment and Follow-up of Colorectal Cancer

Recruiting

• Conditions: Colorectal Cancer; Colorectal Adenoma

• Registration Number: NCT06307938
• Lead Sponsor: Helse Nord-Trøndelag HF

Brief Summary

CoLiQ is a clinical study designed to evaluate the clinical usefulness of circulating tumor DNA (ctDNA) markers found in blood, as a liquid biopsy for diagnosis, prognosis and follow-up of colorectal cancer. The main questions it aims to answer are: 1) Can a panel of ctDNA markers identify CRC patients among the other patients summoned for colonoscopy? and 2) Does the type, number and level of ctDNA markers vary with the subtype and clinical course of CRC? Participants will be asked to answer a questionnaire and give a blood sample at inclusion. In addition, patients with CRC will be asked to give an extra test tube at their routine treatment and follow-up blood sampling.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-06
• Study First Submitted QC: 2024-03-06
• Study First Posted: 2024-03-13
• Study Start: 2025-03-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-30
• Primary Completion: 2026-05
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Patient ≥ 18 years old summoned for colonoscopy
• Patient able to understand and sign written informed consent

Exclusion Criteria

• Patient < 18 years old
• Patient unable to understand or give written informed consent
• Patient unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the investigator as unlikely to complete the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Colorectal cancer	evaluated within 3 months after colonoscopy	Number of patients with colorectal cancer at histology following colonoscopy
Colorectal adenoma	evaluated within 3 months after colonoscopy	Number of patients with colorectal adenoma at histology following colonoscopy
Inflammatory bowel disease	evaluated within 3 months after colonoscopy	Number of patients with inflammatory bowel disease at histology following colonoscopy

Secondary Outcome Measures

Name	Time	Method
Treatment response	Within the 5 years following diagnosis of colorectal cancer	Treatment response among colorectal cancer patients as measured by todays standards of follow-up (CEA, CT-scans, colonoscopy)
Recurrence	Within 5 years following treatment with curative intent for colorectal cancer	Recurrence of colorectal cancer among patients treated curatively.
Death	Within 5 years following diagnosis of colorectal cancer	Death among patients with colorectal cancer

Trial Locations

Locations (1)

Nord-Trøndelag Hospital Trust; 🇳🇴 Levanger, Norway