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

Colorectal Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04684134
• Other study ID #: 2019-SR-020
• Status: Completed
• Start date: June 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: December 2020
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2800
• Est. completion date: June 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Polyp
• Polyps

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)

Bailie L, Loughrey MB, Coleman HG. Lifestyle Risk Factors for Serrated Colorectal Polyps: A Systematic Review and Meta-analysis. Gastroenterology. 2017 Jan;152(1):92-104. doi: 10.1053/j.gastro.2016.09.003. Epub 2016 Sep 14. Review. — View Citation

Øines M, Helsingen LM, Bretthauer M, Emilsson L. Epidemiology and risk factors of colorectal polyps. Best Pract Res Clin Gastroenterol. 2017 Aug;31(4):419-424. doi: 10.1016/j.bpg.2017.06.004. Epub 2017 Jun 28. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographic and clinicopathological characteristics of participants with polyps	demographic and clinicopathological characteristics	1 year
Secondary	Independent high-risk factors of participants with polyps	high-risk factors	1 year