NCT05653960

Brief Summary

This study aims to establish a multicenter registry platform to capture clinical data from subjects undergoing colorectal EMR and ESD.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
94mo left

Started Dec 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet 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 Progress16%
Dec 2024Dec 2033

First Submitted

Initial submission to the registry

December 8, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 16, 2022

Completed
2 years until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2033

Last Updated

August 27, 2024

Status Verified

July 1, 2024

Enrollment Period

9.1 years

First QC Date

December 8, 2022

Last Update Submit

August 26, 2024

Conditions

Keywords

Endoscopic mucosal resectionEndoscopic submucosal dissection

Outcome Measures

Primary Outcomes (2)

  • Curative resection rate of EMR or ESD for colorectal neoplasms

    The short- and long-term clinical efficacy outcomes of colorectal EMR or ESD

    10 years

  • Adverse event rate of EMR or ESD for colorectal neoplasms

    The short- and long-term clinical safety outcomes of colorectal EMR or ESD

    10 years

Study Arms (1)

Subjects who undergo EMR or ESD

Subjects who undergo EMR or ESD for colorectal lesions

Other: EMR or ESD

Interventions

Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are two main endoscopic treatment options for colorectal neoplasms

Subjects who undergo EMR or ESD

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects who undergo EMR or ESD for colorectal lesions.

You may qualify if:

  • Subjects who undergo EMR or ESD for colorectal lesions.

You may not qualify if:

  • Not applicable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

s-formylglutathione hydrolase

Condition Hierarchy (Ancestors)

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

Study Officials

  • Louis Lau

    Prince of Wales Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

December 8, 2022

First Posted

December 16, 2022

Study Start

December 1, 2024

Primary Completion (Estimated)

December 31, 2033

Study Completion (Estimated)

December 31, 2033

Last Updated

August 27, 2024

Record last verified: 2024-07

Locations