Menu
Recruiting NCT06307938

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

Observational Colorectal Cancer Colorectal Adenoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: liquid biopsy.
Who it may be relevant to
Registry conditions: Colorectal Cancer, Colorectal Adenoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Norway
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Diagnostic test liquid biopsy
    based on a panel of circulating tumor DNA markers

Primary outcome measures

  • Colorectal cancer [Time frame: evaluated within 3 months after colonoscopy]
  • Colorectal adenoma [Time frame: evaluated within 3 months after colonoscopy]
  • Inflammatory bowel disease [Time frame: evaluated within 3 months after colonoscopy]
Secondary outcome measures (3)
  • Recurrence [Time frame: Within 5 years following treatment with curative intent for colorectal cancer]
  • Death [Time frame: Within 5 years following diagnosis of colorectal cancer]
  • Treatment response [Time frame: Within the 5 years following diagnosis of colorectal cancer]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Norway · 1 center
  • Nord-Trøndelag Hospital Trust — Levanger

Identifiers

NCT: NCT06307938 · 619020

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗