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临床试验/NCT04531930
NCT04531930尚未招募不适用

Cohort Study on Colorectal Adenoma Canceration in Familial Adenomatous Polyposis

Changhai Hospital1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
124
试验地点
1
主要终点
3yCR

研究概览

简要总结

The current internationally accepted treatment method for familial adenomatous polyposis is prophylactic total colorectal resection combined with endoscopic follow-up. However, total colorectal resection will bring a sharp decline in the quality of life of patients. Therefore, how to improve treatment methods and improve the quality of life for such patients under the premise of medical quality is the current medical focus. This study intends to establish three parallel observation cohorts, namely the surgical treatment group, the intensive colonoscopy treatment group, and the autonomous monitoring group. During the three-year study period, the investigators observed changes in the number of adenomas, carcinogenesis, and medical expenses in each group during the 3-year study period, and compared the groups to determine whether the intensive colonoscopy therapy has the possibility of delaying or replacing preventive surgery.

详细描述

Familial adenomatous polyposis is a kind of colorectal cancer syndrome, which belongs to rare diseases. It is estimated that the number of patients in China is about 100,000, accounting for about 1% of all colorectal cancer patients. This type of patients onset between the ages of ten and thirty years old. The typical manifestation is the growth of tens to thousands of colorectal adenomas, and the lifetime risk of colorectal cancer is close to 100%, accompanied by multiple extraintestinal manifestations . Without treatment, the average life span is 40-50 years. The current internationally accepted treatment method is prophylactic total colorectal resection combined with endoscopic follow-up. This program has a significant effect and can extend life expectancy by 10-20 years. However, total colorectal resection will bring a sharp decline in the quality of life of patients. The patients will lose many abilities (working ability, social ability, fertility, etc.) from the age of 20, and the prolonged survival period also brings more misery. This, in turn, also reduces the compliance of treatment. Many patients refuse to accept surgery and turn to endoscopic treatment or even give up treatment. However, there is currently no evidence that methods other than prophylactic surgery can effectively control the risk of colorectal cancer in such patients. Therefore, how to improve treatment methods and improve the quality of life for such patients under the premise of medical quality is the current medical focus. This study intends to establish three parallel observation cohorts, namely the surgical treatment group, the intensive colonoscopy treatment group, and the autonomous monitoring group. Among them, the intensive colonoscopy treatment group will be treated with colonoscopy intensive treatment (that is, colonoscopy treatment is performed every 3 months, Carry out colorectal tumor reduction in segments, and continue to control the growth of adenomas several times) for patients who refuse surgery. During the three-year study period, the investigators observed changes in the number of adenomas, carcinogenesis, and medical expenses in each group during the 3-year study period, and compared the groups to determine whether the intensive colonoscopy therapy has the possibility of delaying or replacing preventive surgery, so as to explore ways to improve the quality of life of such patients.

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 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • The initial number of polyps is between 100-1000 visually;
  • Pathological diagnosis of multiple lesions confirmed colorectal adenoma;
  • Germline mutation detection is clearly a point mutation or large deletion of APC gene;
  • No cancer or distant metastasis.

排除标准

  • Age <18, or >40 years old;
  • The initial number of polyps is <100, or >1000;
  • The polyp has become cancerous or has suspected distant metastasis;
  • Patients with intestinal obstruction, intestinal perforation, intestinal bleeding and other patients who need emergency surgical resection;
  • Past history of colorectal surgery;
  • Suffering from malignant tumors in other parts and requiring treatment or using chemotherapy drugs or NSAIDs;
  • The patient has contraindications to colonoscopy;
  • Patients or family members cannot understand the conditions and goals of this study;
  • The patient plans to receive surgical treatment of preventive colorectal resection;
  • Other reasons considered by the study doctor to be inappropriate for inclusion in the study.

结局指标

主要结局

3yCR

时间窗: 3 years

3 year Cancerous rate

次要结局

  • 3yOSR(3 years)
  • Adenoma number Change(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

En-Da Yu

Professor

Changhai Hospital

研究点 (1)

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