NCT04815525

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Jan 2023Dec 2026

First Submitted

Initial submission to the registry

March 23, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

3.9 years

First QC Date

March 23, 2021

Last Update Submit

February 8, 2024

Conditions

Keywords

colonoscopy

Outcome Measures

Primary Outcomes (1)

  • Culumative incidence of advanced colorectal neoplasia

    high-risk adenomas or CRC after 15 years of index conoloscopy

    15 years

Secondary Outcomes (1)

  • CRC-related mortality rate

    15 years

Study Arms (4)

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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Specialist

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 25, 2021

Study Start

January 1, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 9, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

There are no plans to share IPD with other researchers

Locations