Circulating Tumor DNA in Patients Summoned for Colonoscopy; - a Liquid Biopsy for Detection, Characterization, Individualized Treatment and Follow-up of Colorectal Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Helse Nord-Trøndelag HF
- Enrollment
- 3000
- Locations
- 1
- Primary Endpoint
- Colorectal cancer
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Colorectal cancer
Time Frame: evaluated within 3 months after colonoscopy
Number of patients with colorectal cancer at histology following colonoscopy
Colorectal adenoma
Time Frame: evaluated within 3 months after colonoscopy
Number of patients with colorectal adenoma at histology following colonoscopy
Inflammatory bowel disease
Time Frame: evaluated within 3 months after colonoscopy
Number of patients with inflammatory bowel disease at histology following colonoscopy
Secondary Outcomes
- Treatment response(Within the 5 years following diagnosis of colorectal cancer)
- Recurrence(Within 5 years following treatment with curative intent for colorectal cancer)
- Death(Within 5 years following diagnosis of colorectal cancer)