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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04684134

Enrollment

2800

Registered

2020-12-24

Start date

2019-06-01

Completion date

2020-06-01

Last updated

2020-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Polyp

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.

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Demographic and clinicopathological characteristics of participants with polyps	1 year	demographic and clinicopathological characteristics

Secondary

Measure	Time frame	Description
Independent high-risk factors of participants with polyps	1 year	high-risk factors

Countries

China

Outcome results