Clinical trial · Interventional
ctDNA and TEP Levels in Colon Cancer
Determination of ctDNA and TEP Levels in Patients With Colon Cancer Receiving Neoadjuvant Systemic Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Additional Peripheral Venous Blood Sampling for ctDNA and TEP Biomarker Analysis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Biomarker Assessment Cohort
- description
- 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.
- interventionNames
- Procedure: Additional Peripheral Venous Blood Sampling for ctDNA and TEP Biomarker Analysis
Primary outcomes (1)
- measure
- Percentage of Participants With Major Pathological Response in the Post-Neoadjuvant ctDNA Assessment
- timeFrame
- From completion of neoadjuvant systemic therapy to pathological assessment after surgical resection, approximately 3 to 6 months.
- description
- Major pathological response will be assessed by histopathological evaluation of the surgical resection specimen after completion of neoadjuvant systemic therapy. The unit of measure will be the percentage of participants with major pathological response. ctDNA status after completion of neoadjuvant systemic therapy will be used as a pre-specified stratification variable in the statistical analysis.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available