ctDNA and TEP Levels in Colon Cancer

Sponsor
Institute of Oncology Ljubljana
Study ID
NCT07701408
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Additional Peripheral Venous Blood Sampling for ctDNA and TEP Biomarker Analysis — PROCEDURE
    Additional peripheral venous blood samples will be collected at predefined time points before treatment, during systemic treatment, before surgery, and after surgery. Samples will be analyzed for circulating tumor DNA (ctDNA) and tumor-educated platelets (TEP).

Study Details

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 Dates

First listed
Jul 14, 2026
Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Other: Biomarker Assessment Cohort
    Participants with stage III colon cancer receiving neoadjuvant systemic therapy according to routine clinical practice will undergo additional peripheral venous blood sampling at predefined time points for ctDNA and TEP biomarker analysis.

Primary Outcome Measure

Percentage of Participants With Major Pathological Response in the Post-Neoadjuvant ctDNA Assessment [ Time Frame: From completion of neoadjuvant systemic therapy to pathological assessment after surgical resection, approximately 3 to 6 months. ]

Central Contacts

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