The Longterm Risk of Advanced Colorectal Neoplasia After Colonoscopy - A Population-based Cohort Study in Hong Kong (ACNC)

The primary objective of this study is to analyze the 15-year cumulative incidence of advanced colorectal neoplasia and CRC-related mortality after the index colonoscopy.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Colorectal Neoplasia

Detailed Description

This is a territory-wide retrospective observational cohort study using the Clinical Data Analysis and Reporting System (CDARS). We will identify patients from CDARS with colonoscopy performed from 1 January 2000 to 31 October 2020. Other relevant diagnoses, procedures, concomitant drugs, laboratory parameters and pathology results will be retrieved and studied.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Felix Sia; Phone Number: +85226370428; Email: felix.sia@cuhk.edu.hk
• Study Contact Backup: Name: Thomas Lam; Phone Number: +85226370428; Email: thomas.lam@cuhk.edu.hk

Study Locations

• Hong Kong
  • New Territories
    • Shatin, New Territories, Hong Kong
      • Recruiting
      • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

We will identify patients from CDARS with colonoscopy performed from 1 January 2000 to 31 October 2020. Other relevant diagnoses, procedures, concomitant drugs, laboratory parameters and pathology results will be retrieved and studied.

Description

Inclusion Criteria:

1. All patients with colonoscopy performed in HA hospitals during the study period would be eligible for screening.

Exclusion Criteria:

1. Patients with documented personal history of colorectal cancers before the study period would be excluded.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Normal finding; Colonoscopy finding normal
Hyperplastic polyps; Colonoscopy finding of hyperplastic polyps
Low-risk adenomas; Colonoscopy finding of low-risk adenomas
High-risk adenomas; Colonoscopy finding of high-risk adenomas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Culumative incidence of advanced colorectal neoplasia	high-risk adenomas or CRC after 15 years of index conoloscopy	15 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRC-related mortality rate	the rate of mortality due to CRC-related incidents	15 years

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: colonoscopy
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2020.597

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There are no plans to share IPD with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No