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Brief Title: Circulating Tumour DNA (ctDNA) as a Prognostic and Predictive Marker in Colorectal Cancer - a Pilot Study
Official Title: A Pilot Study Investigating the Feasibility to Perform Prospective Circulating Tumor DNA (ctDNA) Profiling in Patients With Colorectal Cancer
Study ID: NCT04726800
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Akershus Univeristy Hospital, Oslo, , Norway
Sahlgrenska University Hospital, Göteborg, , 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
Name: Anna Martling, Professor
Affiliation: Karolinska Institutet
Role: PRINCIPAL_INVESTIGATOR