Human Microecology；Colorectal Disease；Auxiliary DiagnosisNCT05998915
A Multi-center Study on Human Microecology Assisted Diagnosis of Colorectal Cancer
An observational study of Human Microecology；Colorectal Disease；Auxiliary Diagnosis, run by Zhujiang Hospital at 1 site in China.
Trial summary
As for this research，we want to find whether the intestinal microecology (flora, peptidoglycan fragments) have certain distribution characteristics in colorectal diseases; whether it can predict the development of disease/as a prognostic indicator. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Human Microecology；Colorectal Disease；Auxiliary Diagnosis
- What is being tested?
- observe only
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 31 Dec 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 2500
Who may be able to join
- people who is going to get the colonoscopy examination
Who cannot join
- people who was diagnosed as one cancer，expect for CRC; who has had the antibiotics or the medicine that treats for colorectal disease, except for medical probiotics, in one month; who has had the laxative and the colonscopy in one week; who had a operation in three month.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
Hongwei Zhou, Professor, 18688489622, hzhou@smu.edu.cn
About this study
As for this research，we want to find whether the intestinal microecology (flora, peptidoglycan fragments) have certain distribution characteristics in colorectal diseases; whether it can predict the development of disease/as a prognostic indicator.
Read the detailed description
We even want to find whether it can predict the development of disease/as a prognostic indicator.
- Being tested
- observe only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observe onlyOther
observe only
| Study group | Role | What they receive |
|---|---|---|
| Colorectal Cancer(CRC) | People who is diagnosed with CRC by colonoscopy and pathological biopsy Receives: Other: observe only | |
| Inflammatory Bowel Disease | People who is diagnosed with IBD by colonoscopy and pathological biopsy Receives: Other: observe only | |
| Colorectal adenoma(CRA)/adenomatous polyposis | People who is diagnosed with CRA by colonoscopy and pathological biopsy Receives: Other: observe only | |
| Non-adenomatous polyps | People who is diagnosed with non-adenomatous polyps by colonoscopy and pathological biopsy Receives: Other: observe only | |
| Irritable bowel syndrome | People who is diagnosed with IBS by colonoscopy and pathological biopsy Receives: Other: observe only | |
| normal | People who has no obvious abnormality in the whole colon Receives: Other: observe only |
What is being measured
The primary outcome is the main question the study is designed to answer.
collect specimen before colonscope
collect fecal，saliva，urine，blood to assess the level of the activation of NOD2，cytokines
Measured: Baseline (before colonscope)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Mar 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Microecology；Colorectal Disease；Auxiliary DiagnosisStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998915
- Sponsor's protocol ID
- CALM2102
- Status last verified
- Mar 2023
- First submitted
- 11 Aug 2023
- Last updated
- 29 Nov 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 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Study on Human Microecology Assisted Diagnosis of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05998915
- Acronym / sponsor ID
- CALM2102
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Aug 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.
As for this research，we want to find whether the intestinal microecology (flora, peptidoglycan fragments) have certain distribution characteristics in colorectal diseases; whether it can predict the development of disease/as a prognostic indicator.
Detailed description
We even want to find whether it can predict the development of disease/as a prognostic indicator.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Colorectal Cancer(CRC) | – | Other: observe onlyPeople who is diagnosed with CRC by colonoscopy and pathological biopsy |
| Inflammatory Bowel Disease | – | Other: observe onlyPeople who is diagnosed with IBD by colonoscopy and pathological biopsy |
| Colorectal adenoma(CRA)/adenomatous polyposis | – | Other: observe onlyPeople who is diagnosed with CRA by colonoscopy and pathological biopsy |
| Non-adenomatous polyps | – | Other: observe onlyPeople who is diagnosed with non-adenomatous polyps by colonoscopy and pathological biopsy |
| Irritable bowel syndrome | – | Other: observe onlyPeople who is diagnosed with IBS by colonoscopy and pathological biopsy |
| normal | – | Other: observe onlyPeople who has no obvious abnormality in the whole colon |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 2500
Key inclusion criteria (1 listed)
- people who is going to get the colonoscopy examination
Key exclusion criteria (1 listed)
- people who was diagnosed as one cancer，expect for CRC; who has had the antibiotics or the medicine that treats for colorectal disease, except for medical probiotics, in one month; who has had the laxative and the colonscopy in one week; who had a operation in three month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observe onlyobserve only | Other | Colorectal Cancer(CRC), Colorectal adenoma(CRA)/adenomatous polyposis, Inflammatory Bowel Disease, Irritable bowel syndrome, Non-adenomatous polyps, normal |
Primary outcome
collect specimen before colonscope
Time frame: Baseline (before colonscope)
collect fecal，saliva，urine，blood to assess the level of the activation of NOD2，cytokines
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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.
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 Human Microecology；Colorectal Disease；Auxiliary Diagnosis, run by Zhujiang Hospital 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 1 inclusion and 1 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 29 Nov 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 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?
Contact 钟 典 (18928794133, vmojito@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
collect specimen before colonscope (time frame: Baseline (before colonscope)). 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 29 Nov 2023.