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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Additional Peripheral Venous Blood Sampling for ctDNA and TEP Biomarker Analysis
Procedure/SurgeryAdditional 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).
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Biomarker Assessment CohortOther 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants With Major Pathological Response in the Post-Neoadjuvant ctDNA Assessment
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.
Time frame
From completion of neoadjuvant systemic therapy to pathological assessment after surgical resection, approximately 3 to 6 months.Secondary outcomes
1
Percentage of Participants With Objective Radiological Response According to RECIST 1.1
Radiological response will be assessed according to RECIST version 1.1 using routine preoperative imaging. Objective radiological response will include complete response and partial response. The unit of measure will be the percentage of participants with objective radiological response. ctDNA status after completion of neoadjuvant therapy will be used as a pre-specified stratification variable in the statistical analysis.
Time frame
From baseline to preoperative radiological assessment, approximately 3 to 6 months.2
Percentage of Participants Alive and Disease-Free at 12 Months After Surgical Resection
Disease-free status will be assessed using routine clinical, radiological, and follow-up documentation. The outcome will be defined as being alive and without disease recurrence at 12 months after surgical resection. The unit of measure will be the percentage of participants alive and disease-free at 12 months. ctDNA status after completion of neoadjuvant therapy will be used as a pre-specified stratification variable in the statistical analysis.
Time frame
12 months after surgical resection.3
Percentage of Participants With Early Disease Recurrence Within 12 Months After Surgical Resection in the Postoperative ctDNA Assessment
Early disease recurrence will be assessed using routine clinical, radiological, and follow-up documentation. The unit of measure will be the percentage of participants with disease recurrence within 12 months after surgical resection. Postoperative ctDNA status will be used as a pre-specified stratification variable in the statistical analysis.
Time frame
Up to 12 months after surgical resection.4
Percentage of Participants With Early Disease Recurrence Within 12 Months After Surgical Resection in the Postoperative TEP Assessment
Early disease recurrence will be assessed using routine clinical, radiological, and follow-up documentation. The unit of measure will be the percentage of participants with disease recurrence within 12 months after surgical resection. Postoperative tumor-educated platelet status will be used as a pre-specified stratification variable in the statistical analysis.
Time frame
Up to 12 months after surgical resection.Sponsors and contacts
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Source ClinicalTrials.gov
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