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

April 25, 2025 updated by: Helse Nord-Trøndelag HF

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Diagnostic test: liquid biopsy

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Study Locations

Norway
- - Levanger, Norway, N-7600
    - Recruiting
    - Nord-Trøndelag Hospital Trust
    - Contact:
      
      Siv S Brenne, MD, PhD
      
      Phone Number: +47 74098000
      
      Email: siv.brenne@hnt.no

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colorectal cancer Time Frame: evaluated within 3 months after colonoscopy	Number of patients with colorectal cancer at histology following colonoscopy	evaluated within 3 months after colonoscopy
Colorectal adenoma Time Frame: evaluated within 3 months after colonoscopy	Number of patients with colorectal adenoma at histology following colonoscopy	evaluated within 3 months after colonoscopy
Inflammatory bowel disease Time Frame: evaluated within 3 months after colonoscopy	Number of patients with inflammatory bowel disease at histology following colonoscopy	evaluated within 3 months after colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence Time Frame: Within 5 years following treatment with curative intent for colorectal cancer	Recurrence of colorectal cancer among patients treated curatively.	Within 5 years following treatment with curative intent for colorectal cancer
Death Time Frame: Within 5 years following diagnosis of colorectal cancer	Death among patients with colorectal cancer	Within 5 years following diagnosis of colorectal cancer
Treatment response Time Frame: 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)	Within the 5 years following diagnosis of colorectal cancer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helse Nord-Trøndelag HF

Collaborators

Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

March 6, 2024

First Submitted That Met QC Criteria