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NCT04726800

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

Sponsor: Anna Martling

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2020-10-01

Completion Date

2026-12

Last Updated

2026-08-21

Healthy Volunteers

No

Locations (8)

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