The Longterm Risk of Advanced Colorectal Neoplasia After... | NCT04815525

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

NCT04815525

Sponsor

Chinese University of Hong Kong

Status

Recruiting

Last Update Posted

Feb 9, 2024Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Colorectal Neoplasia
Colorectal Cancer

Interventions

Not provided

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Dec 1, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Mar 23, 2021

First Submission Date that Met QC Criteria

Mar 23, 2021

First Posted Date

Mar 25, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2024

Last Update Posted Date

Feb 9, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Louis Ho Shing Lau, Resident Specialist, Chinese University of Hong KongPrincipal Investigator

Lead Sponsor

Chinese University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Felix Sia	Contact	+85226370428		felix.sia@cuhk.edu.hk
Thomas Lam	Contact	+85226370428		thomas.lam@cuhk.edu.hk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prince of Wales Hospital	Recruiting	Shatin	New Territories		Hong Kong

IPD Sharing Statement Module

Plan to Share IPD

Description

There are no plans to share IPD with other researchers

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided