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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHelse Nord-Trøndelag HF

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patient ≥ 18 years old summoned for colonoscopy

Patient able to understand and sign written informed consent

Disqualifiers

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

Trial population

Patients summoned for colonoscopy at their local public hospital

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • liquid biopsy

    Diagnostic test

    based on a panel of circulating tumor DNA markers

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Colorectal cancer

Number of patients with colorectal cancer at histology following colonoscopy

Time frame
evaluated within 3 months after colonoscopy
2

Colorectal adenoma

Number of patients with colorectal adenoma at histology following colonoscopy

Time frame
evaluated within 3 months after colonoscopy
3

Inflammatory bowel disease

Number of patients with inflammatory bowel disease at histology following colonoscopy

Time frame
evaluated within 3 months after colonoscopy

Secondary outcomes

1

Recurrence

Recurrence of colorectal cancer among patients treated curatively.

Time frame
Within 5 years following treatment with curative intent for colorectal cancer
2

Death

Death among patients with colorectal cancer

Time frame
Within 5 years following diagnosis of colorectal cancer
3

Treatment response

Treatment response among colorectal cancer patients as measured by todays standards of follow-up (CEA, CT-scans, colonoscopy)

Time frame
Within the 5 years following diagnosis of colorectal cancer

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Helse Nord-Trøndelag HF

Lead sponsor

Norwegian University of Science and Technology

Collaborator