Determination of ctDNA and TEP Levels in Patients With Colon Cancer Receiving Neoadjuvant Systemic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Major Pathological Response in the Post-Neoadjuvant ctDNA Assessment
研究概览
简要总结
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.
详细描述
This is a prospective interventional longitudinal cohort study of adult patients with histologically confirmed stage III colon adenocarcinoma who are planned to receive neoadjuvant systemic therapy followed by surgical resection with curative intent.
The study will evaluate the dynamics of circulating tumor DNA (ctDNA) and tumor-educated platelets (TEP) during neoadjuvant treatment and follow-up. Neoadjuvant systemic therapy will be selected according to routine clinical practice and tumor biology, including mismatch repair status. Patients with pMMR tumors may receive chemotherapy, while patients with dMMR tumors may receive immunotherapy, according to standard clinical decision-making.
The research intervention consists of additional peripheral venous blood sampling at predefined time points before treatment, during systemic treatment, before surgery, and after surgery. Blood samples will be analyzed for ctDNA and TEP-based biomarkers. Clinical, radiological, pathological, and follow-up data will be collected from routine medical documentation.
The primary objective is to determine whether the presence of ctDNA after completion of neoadjuvant systemic therapy is associated with pathological tumor response, defined as major pathological response (MPR), in patients with stage III colon cancer. Secondary and exploratory objectives include evaluation of the association between ctDNA, TEP profiles, radiological response, recurrence-free outcomes, and disease-free outcomes.
Approximately 80 participants will be enrolled. The study is academic and non-commercial. Participants will not receive experimental drugs as part of this study, and all therapeutic and diagnostic procedures will follow established clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •Ability to understand the study and provide written informed consent.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Additional Peripheral Venous Blood Sampling for ctDNA and TEP Biomarker Analysis (Procedure)
结局指标
主要结局
Percentage of Participants With Major Pathological Response in the Post-Neoadjuvant ctDNA Assessment
时间窗: From completion of neoadjuvant systemic therapy to pathological assessment after surgical resection, approximately 3 to 6 months.
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.
次要结局
- Percentage of Participants With Objective Radiological Response According to RECIST 1.1(From baseline to preoperative radiological assessment, approximately 3 to 6 months.)
- Percentage of Participants Alive and Disease-Free at 12 Months After Surgical Resection(12 months after surgical resection.)
- Percentage of Participants With Early Disease Recurrence Within 12 Months After Surgical Resection in the Postoperative ctDNA Assessment(Up to 12 months after surgical resection.)
- Percentage of Participants With Early Disease Recurrence Within 12 Months After Surgical Resection in the Postoperative TEP Assessment(Up to 12 months after surgical resection.)
- Percentage of Participants With Major Pathological Response in the Baseline ctDNA Assessment(From baseline to pathological assessment after surgical resection, approximately 3 to 6 months.)
- Percentage of Participants With Pathological Complete Response After Surgical Resection(From baseline to pathological assessment after surgical resection, approximately 3 to 6 months.)