NCT06091137

Brief Summary

Colorectal cancer (CRC) is one of the most common cancer worldwide. Initiation and progression of CRC involve complex interactions among genetic, epigenetic and environmental factors. Given that hereditary and familial CRC only accounts for 2% to 5% of cases, environmental factors are the key triggers of CRC. Emerging evidence has indicated that gut microbes are an important environmental factor promoting CRC development. Gut dysbiosis has been shown to promote colorectal carcinogenesis in mice. Several individual bacterial species, such as the enterotoxigenic Bacteroides fragilis (ETBF), Fusobacterium nucleatum and Peptostreptococcus anaerobius, could exert carcinogenic effects by inducing direct DNA damage, oxidative damage and activating oncogenic signaling pathways. Recent studies have shown that the appendix plays an important role in maintaining homeostasis and biodiversity of gut microbiome by providing an ideal ecological niche for commensal bacteria and production of immunoglobulin A. Considering the key role of microorganisms in gastrointestinal pathophysiology, absence of appendix may result in disruption of microbiome homeostasis, which could potentially influence the risk of developing CRC. In terms of epidemiological evidence, the association of appendectomy with the risk of CRC development has been controversial, and to date no consensus has been attained. Although gut microorganisms could be a crucial pivot between appendectomy and risk of subsequent CRC development, the direct contribution of appendectomy and the underlying mechanisms are still largely unexplored. In this study, we aim to study

  1. 1.the association between appendectomy and colorectal cancer, and
  2. 2.the role of appendectomy in CRC risk through causing gut microbial dysbiosis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

June 1, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

3 years

First QC Date

October 8, 2023

Last Update Submit

October 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Appendectomy is associated with risk of subsequent CRC incidence

    Individuals underwent appendectomy from January 2000 to December 2020 will be retrieved from a population-based database (CDARS) in Hong Kong. For the control group, individuals without appendectomy between 2000 and 2020 based on the same exclusion criteria will be identified from the total population register of CDARS. For each case of appendectomy, we will select two matched referential individuals from the pool based on the year of birth and gender to study the association between appendectomy and CRC risk.

    3 years

Study Arms (2)

Non-appendectomy controls

Appendectomy cases

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

60000 appendectomy cases and 120000 controls

You may qualify if:

  • Individuals underwent appendectomy from January 2000 to December 2020

You may not qualify if:

  • patients with the age ≤18 years at enrollment;
  • Patients with any malignant diseases or inflammatory bowel disease history before enrollment;
  • Patients with hereditary syndromes of colorectal adenomas or polyps (familial adenomatous polyposis, Lynch syndrome, etc.);
  • Patients that underwent appendectomy for appendiceal neoplasms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Digestive Disease, The Chinese University of Hong Kong

Shatin, 00000, Hong Kong

Location

MeSH Terms

Conditions

Colorectal NeoplasmsAppendicitis

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

October 8, 2023

First Posted

October 19, 2023

Study Start

June 1, 2022

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

October 19, 2023

Record last verified: 2023-10

Locations