Circulation Tumor Cells, Tumor DNA and Immunological Response in Relation to Colonic Stent Placement for Malignant Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- ctDNA/cfDNA levels in relation to colorectal stent placement
研究概览
简要总结
This study aims to investigate levels of circulating cell free DNA (cfDNA), circulating tumor DNA (ctDNA), circulating tumor cells (CTC) and immunological changes after self-expanding metal stent (SEMS) placement for malignant obstruction in the colon, and interpret these levels in relation to overall- and disease-free survival.
Furthermore, we intend to study the opportunity to identify patients with a higher risk of recurrence due to the SEMS placement by monitoring cfDNA and ctDNA-levels, as it may be a potential biomarker to initiate or optimize chemotherapy and thereby ensure a better prognosis for the patients.
详细描述
Study design This prospective study will include 20 patients undergoing SEMS placement as a bridge to elective surgery at Koege- and Slagelse Hospital. Baseline blood samples will be collected before the procedure. After the procedure blood samples will be collected 1, 4, 12 and 24 hours after SEMS placement. After elective surgery a tumor sample will be collected.
Prior to SEMS placement:
When potential candidates are admitted to the hospital they will be presented to the study by the relevant surgeon. The investigators will be contacted, when the patient is admitted to hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages of 18 to 95 years
- •Patients with acute malignant obstruction in the colon.
- •ASA class I-III (Classification of the American Society of Anesthesiology)
- •Signed informed consent
排除标准
- •Known immune-defects
- •Withdrawal of informed consent
- •Bloodtransfusion 24 hours prior to stent-placement until 24 hours after stent-placement.
- •Surgery within 24 hours after stent-placement
- •Known inflammatory bowel disease
结局指标
主要结局
ctDNA/cfDNA levels in relation to colorectal stent placement
时间窗: 2 years
Blood samples will be collected before the treatment and again 1, 4, 12 and 24 hours after stent placement.
次要结局
- Metastatic ability of the cancer cells(2 years)
- Immunological response(2 years)