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

NCT06307938 | Recruiting

• 1 other identifier: 619020
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Colorectal Adenoma

Keywords

Biomarker; Liquid biopsy; ctDNA

Outcome Measures

Primary Outcomes (3)

• Colorectal cancer

  Number of patients with colorectal cancer at histology following colonoscopy

  evaluated within 3 months after colonoscopy

• Colorectal adenoma

  Number of patients with colorectal adenoma at histology following colonoscopy

  evaluated within 3 months after colonoscopy

• Inflammatory bowel disease

  Number of patients with inflammatory bowel disease at histology following colonoscopy

  evaluated within 3 months after colonoscopy

Secondary Outcomes (3)

• Recurrence

  Within 5 years following treatment with curative intent for colorectal cancer

• Death

  Within 5 years following diagnosis of colorectal cancer

• Treatment response

  Within the 5 years following diagnosis of colorectal cancer

Interventions

liquid biopsy DIAGNOSTIC_TEST

based on a panel of circulating tumor DNA markers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients summoned for colonoscopy at their local public hospital

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helse Nord-Trøndelag HF: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

Nord-Trøndelag Hospital Trust

Levanger, N-7600, Norway

RECRUITING

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Investigative Techniques

Central Study Contacts

Eivor A Laugsand, MD, PhD

CONTACT

+47 74075180; eivor.a.laugsand@ntnu.no

Siv S Brenne, MD

CONTACT

+47 74075180; siv.s.brenne@ntnu.no

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 13, 2024
• Study Start: March 10, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

NO (1)