Prospective Multicenter Registry Study to Assess the Frequency of Lynch Syndrome Among Patients With Colorectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Frequency of microsatellite instability and Lynch syndrome
研究概览
简要总结
Prospective multicenter registry study to assess the frequency of Lynch syndrome among patients with colorectal cancer in Russia
详细描述
Blood and tumor samples will be obtained from enrolled patients. 4 ml of venous blood samples will be taken into a tube with EDTA and stored at -20 0C. Tumor samples will be taken during endoscopy or surgical treatment, embedded in paraffin and stored at room temperature.
Microsatellite instability in the tumor tissue will be determined by any method available in the participating center (immunohistochemical or molecular genetic study). In case of detection of microsatellite instability/deficiency in the repair system of unpaired bases blood samples will be analyzed for the fact that germinal mutations in the DNA mismatch repair genes.
Patients will be followed up for 5 years after enrollment. During follow up correlation of spectrum of germinal mutations with clinical data, effectiveness of therapy with immune checkpoint inhibitors, the spectrum of malignant neoplasms in the families of patients with Lynch syndrome, the impact of the presence of microsatellite instability/deficiency in the DNA mismatch repair genes on treatment tactics in the Russian Federation will be assessed.
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
- •Provision of written informed consent;
- •Patients with histologically verified colon adenocarcinoma or patients with histologically verified synchronous neoplasms who have not previously received treatment for a second tumor;
- •Age ≥ 18 years;
- •Absence of antitumor treatment for a real tumor (it is allowed to include patients who have a history of antitumor treatment for other malignant tumors, if the period after treatment is more than 12 months).
- •The ability of the patient, according to the Researcher, to fulfill the requirements of the Protocol;
排除标准
- •Patients receiving chemotherapy or radiotherapy for colon cancer at the time of screening
结局指标
主要结局
Frequency of microsatellite instability and Lynch syndrome
时间窗: up to 5 years
To assess the frequency of microsatellite instability and Lynch syndrome in the population of patients with colorectal cancer in the Russian Federation.
次要结局
- Effectiveness of therapy with immune checkpoint inhibitors(up to 5 years)
- Spectrum of malignant neoplasms(up to 5 years)
- Frequency of occurrence of microsatellite instability/deficiency(up to 5 years)
- Spectrum of germinal mutations in Lynch syndrome(up to 5 years)
- Impact of the presence of microsatellite instability/deficiency(up to 5 years)