Construction of a Prediction Model for Metachronous Colorectal Adenoma

• Conditions: Metachronous Colorectal Adenoma

• Registration Number: NCT05183438
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

The study aimed to explore the independent risk factors for the metachronous colorectal adenoma after endoscopic resection, and construct the prediction model of metachronous colorectal adenoma, in order to provide theoretical basis for postoperative follow-up time of patients, and allocate limited medical resources.

Detailed Description

A large cohort of eligible patients 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 metachronous colorectal adenoma. In the derivation cohort, the LASSO regression method was applied to filter variables and multivariate logistic regression analysis was used to identify important predictors.A prediction model was established based on the results of multivariate logistic regression analysis. The predictive performance of the model was evaluated with respect to its discrimination, calibration and clinical usefulness.

Study Timeline

• Study Start: 2021-05-01
• Status Verified: 2021-12
• Study First Submitted: 2021-12-26
• Study First Submitted QC: 2021-12-26
• Last Update Submitted: 2021-12-26
• Study First Posted: 2022-01-10
• Last Update Posted: 2022-01-10
• Primary Completion: 2022-10-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30000

Inclusion Criteria

• Patients aged ≥18 and ≤75 years old. Patients with complete data on demography and clinicopathology.

Exclusion Criteria

• Patients with a history of inflammatory bowel disease, enterophthisis, familial adenomatous polyposis, P-J syndrome and intestinal lymphoma.

Patients with a previous history of colorectal neoplasm. Patients with a history of severe systemic diseases. Lack of complete clinical data for analysis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Demographic characteristics of patients with metachronous colorectal adenomas checklist	3 year	Age (years), sex (man/woman), family history of colorectal cancer (in first-degree relatives, including parents and siblings), history of smoking (never, past, current), history of alcohol consumption (never, past, current), regular use of non-steroidal anti-inflammatory drugs

Secondary Outcome Measures

Name	Time	Method
Cumulative recurrence rate of metachronous colorectal adenomas	3 year	Cumulative recurrence rate

Trial Locations

Locations (1)

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