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

CoLiQ is an observational 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer; Colorectal Adenoma
• Intervention / Treatment: Diagnostic test: liquid biopsy

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Eivor A Laugsand, MD, PhD; Phone Number: +47 74075180; Email: eivor.a.laugsand@ntnu.no
• Study Contact Backup: Name: Siv S Brenne, MD; Phone Number: +47 74075180; Email: siv.s.brenne@ntnu.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients summoned for colonoscopy at their local public hospital

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colorectal cancer	Colorectal cancer at histology following colonoscopy	evaluated within 3 months after colonoscopy
Colorectal adenoma	Colorectal adenoma at histology following colonoscopy	evaluated within 3 months after colonoscopy
Inflammatory bowel disease	Inflammatory bowel disease at histology following colonoscopy	evaluated within 3 months after colonoscopy

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Helse Nord-Trøndelag HF
• Collaborators: Norwegian University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Biomarker; Liquid biopsy; ctDNA
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenoma
• Other Study ID Numbers: 619020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No