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

Colorectal Cancer Clinical Trial

— CoLiQ  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06307938
• Other study ID #: 619020
• Status: Not yet recruiting
• Start date: January 2025
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: Helse Nord-Trøndelag HF
• Contact: Eivor A Laugsand, MD, PhD
• Phone: +47 74075180
• Email: eivor.a.laugsand[@]ntnu.no
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

CoLiQ is an observational 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Helse Nord-Trøndelag HF	Norwegian University of Science and Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colorectal cancer	Colorectal cancer at histology following colonoscopy	evaluated within 3 months after colonoscopy
Primary	Colorectal adenoma	Colorectal adenoma at histology following colonoscopy	evaluated within 3 months after colonoscopy
Primary	Inflammatory bowel disease	Inflammatory bowel disease at histology following colonoscopy	evaluated within 3 months after colonoscopy
Secondary	Recurrence	Recurrence of colorectal cancer among patients treated curatively.	Within 5 years following treatment with curative intent for colorectal cancer
Secondary	Death	Death among patients with colorectal cancer	Within 5 years following diagnosis of colorectal cancer
Secondary	Treatment response	Treatment response among colorectal cancer patients as measured by todays standards of follow-up (CEA, CT-scans, colonoscopy)	Within the 5 years following diagnosis of colorectal cancer