Colorectal CancerCoLiQNCT06307938
Circulating Tumor DNA in Patients Summoned for Colonoscopy; - a Liquid Biopsy for Detection, Characterization, Individualized Treatment and Follow-up of Colorectal Cancer
An observational study of Colorectal Cancer and Colorectal Adenoma, run by Helse Nord-Trøndelag HF at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colorectal Adenoma
- What is being tested?
- liquid biopsy
- How many people
- 3,000 participants
- Where
- 1 siteNorway
- Study dates
- 10 Mar 2025to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients summoned for colonoscopy at their local public hospital
Who may be able to join
- Patient ≥ 18 years old summoned for colonoscopy
- Patient able to understand and sign written informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Nord-Trøndelag Hospital Trust
Levanger, N-7600
Siv S Brenne, MD, PhD, +47 74098000, siv.brenne@hnt.no
About this study
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.
- Conditions
- Colorectal Cancer, Colorectal Adenoma
- Being tested
- liquid biopsy
- Keywords
- Biomarker, Liquid biopsy, ctDNA
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liquid biopsyDiagnostic test
based on a panel of circulating tumor DNA markers
What is being measured
The primary outcome is the main question the study is designed to answer.
Colorectal cancer
Number of patients with colorectal cancer at histology following colonoscopy
Measured: evaluated within 3 months after colonoscopy
Colorectal adenoma
Number of patients with colorectal adenoma at histology following colonoscopy
Measured: evaluated within 3 months after colonoscopy
Inflammatory bowel disease
Number of patients with inflammatory bowel disease at histology following colonoscopy
Measured: evaluated within 3 months after colonoscopy
Secondary outcomes (3)
Recurrence
Recurrence of colorectal cancer among patients treated curatively.
Measured: Within 5 years following treatment with curative intent for colorectal cancer
Death
Death among patients with colorectal cancer
Measured: Within 5 years following diagnosis of colorectal cancer
Treatment response
Treatment response among colorectal cancer patients as measured by todays standards of follow-up (CEA, CT-scans, colonoscopy)
Measured: Within the 5 years following diagnosis of colorectal cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start10 Mar 2025
- Primary completionMay 2026 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Nord-Trøndelag HF
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307938
- Sponsor's protocol ID
- 619020
- Acronym
- CoLiQ
- Status last verified
- Apr 2025
- First submitted
- 6 Mar 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA in Patients Summoned for Colonoscopy; - a Liquid Biopsy for Detection, Characterization, Individualized Treatment and Follow-up of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06307938
- Acronym / sponsor ID
- CoLiQ / 619020
- Conditions
- Colorectal Cancer, Colorectal Adenoma
- Keywords
- Biomarker, Liquid biopsy, ctDNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Helse Nord-Trøndelag HFUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients summoned for colonoscopy at their local public hospital
Key inclusion criteria (2 listed)
- Patient ≥ 18 years old summoned for colonoscopy
- Patient able to understand and sign written informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liquid biopsybased on a panel of circulating tumor DNA markers | Diagnostic test | – |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Colorectal Adenoma, run by Helse Nord-Trøndelag HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eivor A Laugsand, MD, PhD (+47 74075180, eivor.a.laugsand@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Colorectal cancer (time frame: evaluated within 3 months after colonoscopy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.