Establishment and Validation of a Predictive Model for the Risk of Colorectal Advanced Adenomas

• Conditions: Colorectal Adenoma

• Registration Number: NCT05152082
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

The study aimed to analyze the risk factors of colorectal advanced adenoma and constructe a model to predict the high-risk individuals of harbouring colorectal advanced adenomas, so as to better identify screening participants and provide an important theoretical basis for the prevention of colorectal cancer.

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 colorectal advanced polyps. 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: 2021-06-01
• Study First Submitted: 2021-11-08
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-05
• Study First Posted: 2021-12-09
• Last Update Submitted: 2021-12-28
• Last Update Posted: 2021-12-30
• Primary Completion: 2022-10-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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
height (meters)	1 year	Clinicopathological characteristics of patients with colorectal adenomas
Demographic characteristics of patients with colorectal adenomas checklist	1 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
weight (kilograms)	1 year	Clinicopathological characteristics of patients with colorectal adenomas

Secondary Outcome Measures

Name	Time	Method
The important high-risk factors of colorectal advanced adenoma	1 year	The important high-risk factors with p value \< 0.05

Trial Locations

Locations (1)

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