ctDNA and TEP Levels in Colon Cancer
ConditionColon Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Oncology Ljubljana
About this trial
This interventional cohort study will evaluate circulating tumor DNA (ctDNA) and tumor-educated platelets (TEP) as blood-based biomarkers in adults with stage III colon cancer who are planned to receive neoadjuvant systemic therapy followed by surgical resection.
Treatment will be given according to routine clinical practice and will depend on the biological characteristics of the tumor, including mismatch repair status. Participants will provide additional blood samples at predefined time points before, during, and after treatment and surgery. These samples will be used to analyze ctDNA and TEP and to assess whether changes in these biomarkers are associated with radiological response, pathological response, and disease-free outcomes.
Approximately 80 participants will be enrolled at the Institute of Oncology Ljubljana. Participants will not receive experimental drugs as part of this study.
Eligibility criteria
Qualifiers
Age 18 years or older at the time of enrollment.
Histologically confirmed adenocarcinoma of the colon.
Stage III colon cancer, defined according to the applicable TNM classification based on clinical and imaging assessment.
Confirmed mismatch repair (MMR) status, determined by immunohistochemistry and/or molecular methods.
Disqualifiers
Stage I, II, or IV colon cancer.
Concurrent active malignant disease, except adequately treated non-melanoma skin cancer or carcinoma in situ.
Severe comorbidities or medical conditions that prevent or substantially limit neoadjuvant systemic therapy or surgical resection.
Known autoimmune disease requiring active immunosuppressive treatment in patients with dMMR tumors.
Trial design
Treatments tested in this trial
- Additional Peripheral Venous Blood Sampling for ctDNA and TEP Biomarker Analysis
Treatment groups
80 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov