ctDNA and TEP Levels in Colon Cancer
Starting soon · Not applicable
Conditions studied: Colon Cancer
In brief
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.
Key facts
- Study ID
- NCT07701408
- Run by
- Institute of Oncology Ljubljana
- People needed
- 80
- Starts
- 2026-08-01
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-07-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Planned neoadjuvant systemic therapy according to MMR status, followed by surgical resection with curative intent.
- ECOG performance status 0-2.
- Ability to understand the study and provide written informed consent.
You may not qualify if…
- 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.
- Pregnancy or breastfeeding.
- Inability or unwillingness to provide written informed consent.
Where it is running
- Institute of Oncology Ljubljana — Ljubljana, Slovenia
Full record on ClinicalTrials.gov
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