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

Completed

• Conditions: Colorectal Polyp

• Registration Number: NCT04684134
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2020-05-01
• Study Completion: 2020-06-01
• Study First Submitted: 2020-11-30
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-21
• Last Update Submitted: 2020-12-21
• Study First Posted: 2020-12-24
• Last Update Posted: 2020-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2800

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Demographic and clinicopathological characteristics of participants with polyps	1 year	demographic and clinicopathological characteristics

Secondary Outcome Measures

Name	Time	Method
Independent high-risk factors of participants with polyps	1 year	high-risk factors

Trial Locations

Locations (1)

The First Affiliated Hospital with Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China