Colorectal NeoplasmsIMDCBAITROCCNCT05066048
Intestinal Microecological Dysregulation Caused by Appendectomy Increases the Risk of Colorectal Cancer
An observational study of Colorectal Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
As a good niche for bacterial growth, appendix plays a very important role in maintaining and protecting intestinal symbiotic flora. Appendectomy will lead to intestinal microecological disorders. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2021to 31 Jan 2024
- 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 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with an appendectomy and meet the above conditions
Who may be able to join
- Patients undergoing appendectomy due to appendicitis;
- 6-36 months after appendectomy;
- Patients with no obvious abnormality observed by colonoscopy;
- Age between 20 and 85.
Who cannot join
- A. Any history of malignancy or disease
- Any inflammatory bowel disease (IBD) prior to study inclusion;
- Antibiotics and hormone drugs taken within the last three months;
- Patients with severe systemic diseases (severe diabetes, hypertension or autoimmune diseases, etc.);
- Severe clinical symptoms of digestive tract (severe diarrhea, constipation, purulent disease, etc.) within half a year.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, 710061
About this study
As a good niche for bacterial growth, appendix plays a very important role in maintaining and protecting intestinal symbiotic flora. Appendectomy will lead to intestinal microecological disorders. Therefore, we put forward the hypothesis that "appendectomy leads to intestinal microecological disorders and then increases the risk of colorectal cancer". In this study, the feces of normal controls, appendectomy and patients with colorectal cancer were collected, and the specific changes of intestinal flora after appendectomy were explored in detail from the level of family, genus and species by macrogenomic sequencing. Then through functional gene analysis, metabolic pathway analysis and other methods to explore the molecular mechanism of colorectal cancer risk changes and the changes of microflora involved, and verified by mouse fecal bacteria transplantation animal experiment.
- Conditions
- Colorectal Neoplasms
- Medical subject headings
- Colorectal Neoplasms
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 |
|---|---|---|
| The appendectomy group | Not described | |
| Colorectal cancer group | Not described | |
| Normal group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Species composition of fecal microbial
The types of microorganisms of fecal microbial
Measured: 1 year
Secondary outcomes (3)
weight in kilograms
weight of enrolled patients
Measured: baseline, pre-procedure
height in meters
height of enrolled patients
Measured: baseline, pre-procedure
age in year
age of enrolled patients
Measured: baseline, pre-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start30 Apr 2021
- Primary completion31 Mar 2022
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066048
- Sponsor's protocol ID
- XJTU1AF-CRF-2020-004
- Acronym
- IMDCBAITROCC
- Status last verified
- Mar 2022
- First submitted
- 7 Apr 2021
- Last updated
- 9 May 2022
- 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 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Microecological Dysregulation Caused by Appendectomy Increases the Risk of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05066048
- Acronym / sponsor ID
- IMDCBAITROCC / XJTU1AF-CRF-2020-004
- Conditions
- Colorectal Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 4 Oct 2021 (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.
As a good niche for bacterial growth, appendix plays a very important role in maintaining and protecting intestinal symbiotic flora. Appendectomy will lead to intestinal microecological disorders. Therefore, we put forward the hypothesis that "appendectomy leads to intestinal microecological disorders and then increases the risk of colorectal cancer". In this study, the feces of normal controls, appendectomy and patients with colorectal cancer were collected, and the specific changes of intestinal flora after appendectomy were explored in detail from the level of family, genus and species by macrogenomic sequencing. Then through functional gene analysis, metabolic pathway analysis and other methods to explore the molecular mechanism of colorectal cancer risk changes and the changes of microflora involved, and verified by mouse fecal bacteria transplantation animal experiment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The appendectomy group | – | – |
| Colorectal cancer group | – | – |
| Normal group | – | – |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an appendectomy and meet the above conditions
Key inclusion criteria (4 listed)
- Patients undergoing appendectomy due to appendicitis;
- 6-36 months after appendectomy;
- Patients with no obvious abnormality observed by colonoscopy;
- Age between 20 and 85.
Key exclusion criteria (5 listed)
- A. Any history of malignancy or disease
- Any inflammatory bowel disease (IBD) prior to study inclusion;
- Antibiotics and hormone drugs taken within the last three months;
- Patients with severe systemic diseases (severe diabetes, hypertension or autoimmune diseases, etc.);
- Severe clinical symptoms of digestive tract (severe diarrhea, constipation, purulent disease, etc.) within half a year.
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
Species composition of fecal microbial
Time frame: 1 year
The types of microorganisms of fecal microbial
3 secondary outcomes
weight in kilograms
Time frame: baseline, pre-procedure
height in meters
Time frame: baseline, pre-procedure
age in year
Time frame: baseline, pre-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
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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 Neoplasms, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
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 4 inclusion and 5 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 9 May 2022. 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 China. 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?
Species composition of fecal microbial (time frame: 1 year). 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 9 May 2022.