Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID06307938

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

Led by Helse Nord-Trøndelag HF · Updated on 2025-04-30

3000

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

H

Helse Nord-Trøndelag HF

Lead Sponsor

N

Norwegian University of Science and Technology

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the usefulness of circulating tumor DNA (ctDNA) markers found in blood as a liquid biopsy for diagnosing, predicting outcomes, and monitoring colorectal cancer. The study aims to determine if a panel of ctDNA markers can identify colorectal cancer patients among those scheduled for colonoscopy, and whether the type, number, and level of these markers vary with different colorectal cancer subtypes and their clinical progression. Participants will provide a blood sample and answer a questionnaire at the start of the study. Patients diagnosed with colorectal cancer will be asked to give an additional blood sample during their routine treatment and follow-up visits. This observational study does not involve any experimental treatments but focuses on collecting and analyzing blood samples to assess ctDNA markers. During the study, participants will undergo colonoscopy and be monitored for outcomes such as colorectal cancer, colorectal adenoma, and inflammatory bowel disease within three months after the procedure. Patients with colorectal cancer will be followed for up to five years to track recurrence, treatment response, and survival. The study includes questionnaires and blood tests to gather detailed information and monitor disease progression and response over time.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient 18 years old or older summoned for colonoscopy
  • Patient able to understand and sign written informed consent
Not Eligible

You will not qualify if you...

  • Patient younger than 18 years old
  • Patient unable to understand or give written informed consent
  • Patient unlikely to comply with the protocol or considered unlikely to complete the study by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 3 months

Participants undergo a liquid biopsy based on circulating tumor DNA markers to detect and characterize colorectal cancer and related conditions.

1 to 2 visits depending on colonoscopy scheduling

Long-term Monitoring

Duration - Up to 5 years

Participants are followed for up to 5 years to monitor for cancer recurrence, survival, and treatment response after diagnosis or treatment of colorectal cancer.

Periodic visits as determined by clinical follow-up

Trial Site Locations

Total: 1 location

1

Nord-Trøndelag Hospital Trust

Levanger, Norway, N-7600

Actively Recruiting

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Research Team

E

Eivor A Laugsand, MD, PhD

S

Siv S Brenne, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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