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

Colorectal Adenoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05152082
• Other study ID #: 2021-SR-365
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: December 2021
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Hong Zhu, MD
• Email: zhuhong1059[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma

Locations

Country	Name	City	State
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

Betés M, Muñoz-Navas MA, Duque JM, Angós R, Macías E, Súbtil JC, Herraiz M, De La Riva S, Delgado-Rodríguez M, Martínez-González MA. Use of colonoscopy as a primary screening test for colorectal cancer in average risk people. Am J Gastroenterol. 2003 Dec;98(12):2648-54. — View Citation

Wong MC, Lam TY, Tsoi KK, Hirai HW, Chan VC, Ching JY, Chan FK, Sung JJ. A validated tool to predict colorectal neoplasia and inform screening choice for asymptomatic subjects. Gut. 2014 Jul;63(7):1130-6. doi: 10.1136/gutjnl-2013-305639. Epub 2013 Sep 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographic characteristics of patients with colorectal adenomas checklist	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	1 year
Primary	weight (kilograms)	Clinicopathological characteristics of patients with colorectal adenomas	1 year
Primary	height (meters)	Clinicopathological characteristics of patients with colorectal adenomas	1 year
Secondary	The important high-risk factors of colorectal advanced adenoma	The important high-risk factors with p value < 0.05	1 year