Clinical trial NCT05152082: Establishment and Validation of a Predictive Model for the Risk of Colorectal Advanced Adenomas
Official title: Establishment and Validation of a Predictive Model for the Risk of Colorectal Advanced Adenomas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Adenoma
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Confirmed eligible patients, 18 to 75 years of age, including cases with colorectal advanced adenomas and controls without colorectal advanced adenomas, are enrolled in this study.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Demographic characteristics of patients with colorectal adenomas checklist
timeFrame: 1 year
measure: weight (kilograms)
timeFrame: 1 year
measure: height (meters)
timeFrame: 1 year
Secondary outcomes:
measure: The important high-risk factors of colorectal advanced adenoma
timeFrame: 1 year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
References:
citation: Betes M, Munoz-Navas MA, Duque JM, Angos R, Macias E, Subtil JC, Herraiz M, De La Riva S, Delgado-Rodriguez M, Martinez-Gonzalez 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. doi: 10.1111/j.1572-0241.2003.08771.x.
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.