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Clinical Trials/NCT04684134
NCT04684134
Completed
Not Applicable

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

The First Affiliated Hospital with Nanjing Medical University1 site in 1 country2,800 target enrollmentJune 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Polyp
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Enrollment
2800
Locations
1
Primary Endpoint
Demographic and clinicopathological characteristics of participants with polyps
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2019
End Date
June 1, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Demographic and clinicopathological characteristics of participants with polyps

Time Frame: 1 year

demographic and clinicopathological characteristics

Secondary Outcomes

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

Study Sites (1)

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