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

Sponsor

The First Affiliated Hospital with Nanjing Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT04684134

Collaborator

(none)

2,800

Enrollment

Location

Actual Duration (Months)

232.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Polyp

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

2800 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2019

Actual Primary Completion Date :

May 1, 2020

Actual Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
experimental group patients with colorectal polyps
control group patients without intestinal diseases

Outcome Measures

Primary Outcome Measures

Demographic and clinicopathological characteristics of participants with polyps [1 year]
demographic and clinicopathological characteristics

Secondary Outcome Measures

Independent high-risk factors of participants with polyps [1 year]
high-risk factors

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu	China	210029

Sponsors and Collaborators

The First Affiliated Hospital with Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

The First Affiliated Hospital with Nanjing Medical University

ClinicalTrials.gov Identifier:

NCT04684134

Other Study ID Numbers:

2019-SR-020

First Posted:

Dec 24, 2020

Last Update Posted:

Dec 24, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Polyps

Study Results

No Results Posted as of Dec 24, 2020