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NCT04726800Active, not recruiting

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

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

Source: ClinicalTrials.gov · Last updated 21 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
26 Jan 2021
Start date
1 Oct 2020
Primary completion date
31 Dec 2026
Lead sponsor
Anna Martling
NCT number
NCT04726800

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From 1 Oct 2020 to the primary completion date, 31 Dec 2026
  • 8 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Other

  • Distant metastases
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Akershus Univeristy Hospital
Coordinator of this site? Confirm its status
OsloNorwayUnknown status
Sahlgrenska University Hospital
Coordinator of this site? Confirm its status
GothenburgSwedenUnknown status
Skaraborg Hospital
Coordinator of this site? Confirm its status
SkövdeSwedenUnknown status
Capio Sankt Göran Hospital
Coordinator of this site? Confirm its status
StockholmSwedenUnknown status
Karolinska University Hospital
Coordinator of this site? Confirm its status
StockholmSwedenUnknown status
Danderyd University Hospital
Coordinator of this site? Confirm its status
StockholmSwedenUnknown status
South Hospital
Coordinator of this site? Confirm its status
StockholmSwedenUnknown status
Ersta Hospital
Coordinator of this site? Confirm its status
StockholmSwedenUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.