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Clinical Trials in Norway / NCT04726800
Active, not recruiting Observational

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

NCT04726800 · tracked via the Priya Life Science Norway tracker
Sponsor
Anna Martling
Phase
Observational
Started
2020-10-01
Last updated
2026-08-21

Condition(s) studied

Colorectal Cancer

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Akershus Univeristy Hospital Oslo Norway
Sahlgrenska University Hospital Gothenburg Sweden
Skaraborg Hospital Skövde Sweden
Capio Sankt Göran Hospital Stockholm Sweden
Danderyd University Hospital Stockholm Sweden
Ersta Hospital Stockholm Sweden
Karolinska University Hospital Stockholm Sweden
South Hospital Stockholm Sweden

More Anna Martling trials in Norway

Adjuvant Low Dose Aspirin in Colorectal Cancer Active, not recruiting

Other trials for the same condition

Partial Liver Segment 2/3 Transplantation Study Recruiting
Assessment of Clinically Related Outcomes and Biomarker Analysis for Translational Integration in Colorectal Cancer Recruiting
Exogenous and Endogenous Risk Factors for Early-onset Colorectal Cancer Recruiting
NORCCAP: Norwegian Colorectal Cancer Prevention Trial Active, not recruiting
HAI-Floxuridine, or Liver-Tx, Combined With 2nd Line Chemotherapy Versus 2nd Line Chemotherapy Alone for Patients With Colorectal Liver Metastases and Heavy Tumour Burden. Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04726800 on ClinicalTrials.gov ↗ ← All trials in Norway