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Active, not recruiting

NCT Number: NCT04726800

Circulating Tumour DNA (ctDNA) as a Prognostic and Predictive Marker in Colorectal Cancer - a Pilot Study

In clinical practice, there are currently no biomarkers that can guide colorectal cancer treatment in the primary and curative setting. Improved biomarker-based adjuvant treatments would be of greatest value in order to reduce the risk of relapse. There are reasons to believe that measurements of circulating tumor DNA (ctDNA) in plasma could be used to monitor minimal residual disease after surgery. To address this question, a pilot study was conducted with the purpose to demonstrate the feasibility to perform prospective profiling of ctDNA in a cohort of patients with colorectal cancer stage I-III using the already created Nordic infrastructure for clinical research built up for the ALASCCA trial. If the pilot study proves successful, a large randomised controlled Nordic multicenter study is planned where patients with positive ctDNA 4-6 weeks after radical surgery will be randomised to chemotherapy and/or a biologic agent.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Akershus Univeristy Hospital, Oslo, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Colon or rectal cancer tumor stage I-III planned for radical surgery
  • Clean Colonoscopy or Computed Tomography (CT) colon within 3 months preoperatively or postoperatively but before randomization
  • Patient able to understand and sign written informed consent

Exclusion criteria

  • Distant metastases
  • Other cancers (excluding colorectal cancer or other skin cancer than melanoma) within 3 years from screening
  • Significant medical illness that would interfere with study participation
  • Pregnancy or breastfeeding females
  • Current participation in another clinical trial that will be in conflict with the present study
  • Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude, inability to return for subsequent visits) and/or otherwise considered by the Investigator to be unlikely to complete the study

Treatment and study plan

Primary outcomes

  1. Feasibility and logistics of measuring ctDNA

    Time frame: 2 years

  2. Frequency of positive ctDNA postoperatively in relation to tumour stage and oncological outcome.

    Time frame: 3 years

  3. Frequency of positive ctDNA preoperative converted to negative postoperatively.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Anna Martling

Other

Registry information

Official study title

A Pilot Study Investigating the Feasibility to Perform Prospective Circulating Tumor DNA (ctDNA) Profiling in Patients With Colorectal Cancer

Acronym: CITCCA

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2021
Registry last updated
Aug 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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