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临床试验/NCT04684134
NCT04684134已完成不适用

High-Risk Factors in Patients With Colorectal Polyps a Prospective Case-Control Study

The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 2,800 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,800
试验地点
1
主要终点
Demographic and clinicopathological characteristics of participants with polyps

研究概览

简要总结

This prospective case-control study aimed to analyze and summarize the high-risk factors and susceptible genes of patients with colorectal polyps. According to these high-risk factors, the investigators developed and validated a prediction model for colorectal polyps to identify high-risk individuals, in order to provide clinical basis for the etiology research and the establishment of effective preventive measures.

详细描述

A large cohort of eligible participants were included in the analysis, and classified into derivation and validation cohorts at a ratio of 7:3. Demographic and clinicopathological characteristics of participants were utilized to develop a prediction model for colorectal polyps. In the derivation cohort, the LASSO regression method was applied to filter variables and select the most useful high-risk factors. Multivariate logistic regression analysis was used to identify potential predictors and then a prediction model was established. The predictive performance of the model was evaluated with respect to its discrimination, calibration and clinical usefulness.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject aged ≥18 and ≤80 years old. Subject with complete data on demography and clinicopathology.

排除标准

  • Subject with inflammatory bowel disease, enterophthisis, familial adenomatous polyposis, P-J syndrome and intestinal lymphoma.
  • A history of severe systemic diseases: liver cirrhosis, metabolic syndrome, chronic kidney disease, malignancy.
  • Subject taking blood lipid-lowering drugs, hormone or immunosuppressive agents. Unwillingness to cooperate with questionnaire survey. Lack of complete clinical data for analysis.

结局指标

主要结局

Demographic and clinicopathological characteristics of participants with polyps

时间窗: 1 year

demographic and clinicopathological characteristics

次要结局

  • Independent high-risk factors of participants with polyps(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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