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

NCT04684134 | Completed

• 1 other identifier: 2019-SR-020
• Study Type: observational
• Target: 2,800
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Polyp

Outcome Measures

Primary Outcomes (1)

• Demographic and clinicopathological characteristics of participants with polyps

  demographic and clinicopathological characteristics

  1 year

Secondary Outcomes (1)

• Independent high-risk factors of participants with polyps

  1 year

Study Arms (2)

experimental group

patients with colorectal polyps

control group

patients without intestinal diseases

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 2800 confirmed eligible participants, 18 to 80 years of age, including 2000 cases with colorectal polyps and 800 controls free of colorectal polyps, are enrolled in this study.

You may qualify if:

• Subject aged ≥18 and ≤80 years old. Subject with complete data on demography and clinicopathology.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Related Publications (2)

• Oines 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.

  PMID: 28842051 BACKGROUND

• 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.

  PMID: 27639804 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 24, 2020
• Study Start: June 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: June 1, 2020
• Last Updated: December 24, 2020

Record last verified: 2020-12

Locations

CN (1)