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NCT Number: NCT06307938

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Adenoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nord-Trøndelag Hospital Trust

Levanger, N-7600, Norway

Location status: Recruiting

Location contact

Siv S Brenne, MD, PhD

CONTACT

[email protected]

+47 74098000

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liquid Biopsy

Diagnostic Test

based on a panel of circulating tumor DNA markers

Primary outcomes

  1. Colorectal cancer

    Time frame: evaluated within 3 months after colonoscopy

    Number of patients with colorectal cancer at histology following colonoscopy

  2. Colorectal adenoma

    Time frame: evaluated within 3 months after colonoscopy

    Number of patients with colorectal adenoma at histology following colonoscopy

  3. Inflammatory bowel disease

    Time frame: evaluated within 3 months after colonoscopy

    Number of patients with inflammatory bowel disease at histology following colonoscopy

Secondary outcomes

  1. Recurrence

    Time frame: Within 5 years following treatment with curative intent for colorectal cancer

    Recurrence of colorectal cancer among patients treated curatively.

  2. Death

    Time frame: Within 5 years following diagnosis of colorectal cancer

    Death among patients with colorectal cancer

  3. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Eivor A Laugsand, MD, PhD

CONTACT

[email protected]

+47 74075180

Siv S Brenne, MD

CONTACT

[email protected]

+47 74075180

Sponsors and collaborators

Lead sponsor

Helse Nord-Trøndelag HF

Other

Collaborators

  • Norwegian University of Science and Technology

Registry information

Acronym: CoLiQ

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Mar 13, 2024
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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