Colorectal CancerNCT06091137
Appendectomy and Colorectal Cancer
An observational study of Colorectal Cancer and Appendicitis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer, Appendicitis
- How many people
- 180,000 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2022to 31 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: 60000 appendectomy cases and 120000 controls
Who may be able to join
- Individuals underwent appendectomy from January 2000 to December 2020
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Institute of Digestive Disease, The Chinese University of Hong Kong
Shatin, 00000
About this study
Official title: Altered Gut Microbiome Composition by Appendectomy Contributes to Colorectal Cancer
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
- the association between appendectomy and colorectal cancer, and
- the role of appendectomy in CRC risk through causing gut microbial dysbiosis.
- Conditions
- Colorectal Cancer, Appendicitis
- Medical subject headings
- Colorectal Neoplasms, Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-appendectomy controls | Not described | |
| Appendectomy cases | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Jun 2022
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 180,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun YU, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091137
- Sponsor's protocol ID
- 2022.203
- Status last verified
- Oct 2023
- First submitted
- 8 Oct 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altered Gut Microbiome Composition by Appendectomy Contributes to Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06091137
- Acronym / sponsor ID
- 2022.203
- Conditions
- Colorectal Cancer, Appendicitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180,000 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- the association between appendectomy and colorectal cancer, and
- the role of appendectomy in CRC risk through causing gut microbial dysbiosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-appendectomy controls | – | – |
| Appendectomy cases | – | – |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- 60000 appendectomy cases and 120000 controls
Key inclusion criteria (1 listed)
- Individuals underwent appendectomy from January 2000 to December 2020
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Appendectomy is associated with risk of subsequent CRC incidence
Time frame: 3 years
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Appendicitis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appendectomy is associated with risk of subsequent CRC incidence (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.