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

N/AActive Not RecruitingNCT04726800

Anna Martling300 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Colorectal Cancer

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Feasibility and logistics of measuring ctDNA

Time frame: 2 years

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

Time frame: 3 years

Frequency of positive ctDNA preoperative converted to negative postoperatively.

Time frame: 3 years