Identification of New Non-invasive, Predictive, and Diagnostic Biomarkers for Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Variation in serum biomarkers for CRC
研究概览
简要总结
The study in question is an observational study that aims to identify new non-invasive biomarkers present in the serum of patients with CRC and, subsequently, to create a score capable of predicting the development of CRC.
It is an observational study with 3 enrollment arms:
Arm 1: Patients undergoing surgery at the U.O.C. of Surgery, with a CRC diagnosis;
Arm 2: Subjects with a negative result from the endoscopic examination;
Arm 3: Subjects in whom the presence of an adenoma with high-grade dysplasia is found, a condition considered pre-cancerous.
详细描述
Given the observational nature of the study, patients who access our Institute for diagnostic tests or procedures planned as part of normal clinical practice will be enrolled.
This study involves three enrollment arms:
Arm 1: Patients undergoing surgery at the Department of Surgery with a diagnosis of CRC;
Arm 2: Subjects who attend our Institution's Department of Digestive Endoscopy for a colonoscopy performed for diagnostic purposes, with a negative endoscopic examination result;
Arm 3: Subjects who attend our Institution's Department of Digestive Endoscopy for a colonoscopy performed for diagnostic purposes, or patients undergoing surgery at the Department of Surgery, in whom the presence of an adenoma with high-grade dysplasia, a condition considered pre-cancerous, will be found.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 是
入选标准
- •AIM 1: Patients undergoing surgery at the U.O.C. of Surgery, with a diagnosis of CRC.
- •AIM 2: Subjects without colon disease.
- •AIM 3: Subjects with adenoma and high-grade dysplasia.
排除标准
- •Subject with any other pathology not included in the inclusion criteria.
结局指标
主要结局
Variation in serum biomarkers for CRC
时间窗: From enrollment to the day of the visit after 20 days
Changes in the concentration of potential serum CRC biomarkers in patients with established CRC pre- and post-surgery, patients with an adenoma with high-grade dysplasia, and subjects with no evidence of disease.
次要结局
- Variation of macroconstituents(From enrollment to the day of the visit after 20 days)
研究者
Pasqua Letizia Pesole
Principal Investigator
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis