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