NCT05648240已完成不适用
Proof-of-concept Study of Blood Markers of Tumor Dissemination in Patients With Versus Without Intestinal Polyps
Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年2月23日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Dissemination of circulating tumor cells in blood samples from patients with intestinal polyps compared to patients without polyps
研究概览
简要总结
The study authors hypothesize that in patients with intestinal polyps, tumor cells could disseminate and circulating factors could be secreted by the polyp. These two parameters could become biomarkers to refine the follow-up of patients and to establish targeted therapeutic strategies.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient to be examined by colonoscopy
- •The patient must be a member or beneficiary of a health insurance plan
排除标准
- •The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- •The subject signals their opposition to participate in the study
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
- •Patient pregnant or breastfeeding
- •History of proven cancerous disease
- •Patient followed for a chronic inflammatory bowel disease
研究组 & 干预措施
Patients with polyps
干预措施: Blood test (Other)
Patients without polyps
干预措施: Blood test (Other)
结局指标
主要结局
Dissemination of circulating tumor cells in blood samples from patients with intestinal polyps compared to patients without polyps
时间窗: Day 0
Number of disseminated circulating tumor cells found on the ANGLE Parsortix™ system
次要结局
- Caecal intubation rate according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Total number of histologically validated resected colonic adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Size of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Location of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Location of resected adenomas according to presence of circulating tumor cells, cytokine presence and membrane marker expression(Day 0)
- Concentration of Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in the blood samples between groups.(Day 0)
- Concentration of Tissue Inhibitor of Metalloproteinase 1 (TIMP-1) in the blood samples between groups(Day 0)
- Screening colonoscopy operator (inter-operator tumor detection rate) according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Total number of colonic adenomas visualized according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Method of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Concentration of keratinocyte-derived cytokine (CXCL-1) in the blood samples between groups(Day 0)
- Concentration of Stromal cell-Derived Factor 1 (SDF-1) in the blood samples between groups(Day 0)
- Anti-coagulant therapy according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Known intestinal pathology according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Per-surgical complications according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Concentration of Chemokine ligand 2 (CCL-2) in the blood samples between groups.(Day 0)
- Anti-aggregant therapy according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Reason for screening colonoscopy according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Morphology of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Concentration of Macrophage Colony Stimulating Factor (M-CSF) in the blood samples between groups(Day 0)
- Quality of the preparation according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Recovery of the adenoma after resection according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
- Histology of resected adenomas according to presence of circulating tumor cells, cytokine presence and presence of polyp(Day 0)
研究者
研究点 (1)
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