Establishment and Validation of a Predictive Model for the Risk of Colorectal Advanced Adenomas

NCT05152082 | Unknown

• 1 other identifier: 2021-SR-365
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Adenoma

Outcome Measures

Primary Outcomes (3)

• Demographic characteristics of patients with colorectal adenomas checklist

  Age (years), sex (man/woman), family history of colorectal cancer (in first-degree relatives, including parents and siblings), history of smoking (never, past, current), history of alcohol consumption (never, past, current), regular use of non-steroidal anti-inflammatory drugs

  1 year

• weight (kilograms)

  Clinicopathological characteristics of patients with colorectal adenomas

  1 year

• height (meters)

  Clinicopathological characteristics of patients with colorectal adenomas

  1 year

Secondary Outcomes (1)

• The important high-risk factors of colorectal advanced adenoma

  1 year

Study Arms (2)

patients with colorectal advanced adenomas

patients without colorectal advanced adenomas

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients aged ≥18 and ≤75 years old. Patients with complete data on demography and clinicopathology.

You may not qualify if:

• 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.

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

RECRUITING

Related Publications (2)

• 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.

  PMID: 14687811 BACKGROUND

• 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.

  PMID: 24045331 BACKGROUND

Central Study Contacts

Hong Zhu, MD

CONTACT

zhuhong1059@126.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: December 9, 2021
• Study Start: June 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 30, 2021

Record last verified: 2021-12

Locations

CN (1)