Colorectal Adenoma, Colorectal Cancer
Conditions
Keywords
Biomarker, Liquid biopsy, ctDNA
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.
Interventions
DIAGNOSTIC_TESTliquid biopsy
based on a panel of circulating tumor DNA markers
Sponsors
Norwegian University of Science and Technology
Helse Nord-Trøndelag HF
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Colorectal cancer | evaluated within 3 months after colonoscopy | Number of patients with colorectal cancer at histology following colonoscopy |
| Colorectal adenoma | evaluated within 3 months after colonoscopy | Number of patients with colorectal adenoma at histology following colonoscopy |
| Inflammatory bowel disease | evaluated within 3 months after colonoscopy | Number of patients with inflammatory bowel disease at histology following colonoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence | Within 5 years following treatment with curative intent for colorectal cancer | Recurrence of colorectal cancer among patients treated curatively. |
| Death | Within 5 years following diagnosis of colorectal cancer | Death among patients with colorectal cancer |
| Treatment response | 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) |
Countries
Norway
Contacts
Primary ContactEivor A Laugsand, MD, PhD
Backup ContactSiv S Brenne, MD
Outcome results
None listed