Colorectal CancerNCT06379412
A Cross-sectional Study on the Association of Peptidoglycan Fragments Derived From Gut Microbiota With Colorectal Cancer
An observational study of Colorectal Cancer, run by Zhujiang Hospital at 1 site in China.
Trial summary
The goal of this observational study is to explore the association of peptidoglycan fragments derived from gut microbiota with colorectal cancer (CRC). The main question it aims to answer is: Are peptidoglycan fragments from the gut microbiota associated with the progression of colorectal cancer? Participants will… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to Dec 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Meet eligibility criteria
Who may be able to join
- People who underwent total colonoscopy in gastroenteroscopy room.
- People who agree to participate in this study and are willing to sign informed consent.
Who cannot join
- Previous diagnosis of malignant tumors other than colorectal cancer.
- Received any of the following drug treatments within 1 month before sample collection: ① Drugs used for the treatment of colorectal diseases; ② Antibiotics; ③probiotics; ④ Laxatives.
- Patients with a family history of colorectal cancer.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
He Xiaolong, Professor, 186 2007 1640, 307660349@qq.com
About this study
The goal of this observational study is to explore the association of peptidoglycan fragments derived from gut microbiota with colorectal cancer (CRC). The main question it aims to answer is: Are peptidoglycan fragments from the gut microbiota associated with the progression of colorectal cancer? Participants will provide biological specimens (blood, feces, colon tissue obtained during surgery)
Read the detailed description
To explore whether peptidoglycan fragments can be used as screening or diagnostic indicators for colorectal cancer
- Conditions
- Colorectal Cancer
- Being tested
- observational study, no intervention
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational study, no interventionOther
observational study, no intervention
| Study group | Role | What they receive |
|---|---|---|
| Colorectal Cancer(CRC) | People who are diagnosed with CRC by colonoscopy and pathological biopsy Receives: Other: observational study, no intervention | |
| Colorectal adenoma(CRA) | People who are diagnosed with CRA by colonoscopy and pathological biopsy Receives: Other: observational study, no intervention | |
| Colorectal polyp(CRP) | People who are diagnosed with CRP by colonoscopy and pathological biopsy Receives: Other: observational study, no intervention | |
| Healthy | People who have no obvious abnormality in the whole colon Receives: Other: observational study, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPLC-MS/MS was used to detect peptidoglycan fragment content in biological specimens of 200 participants
The content of peptidoglycan fragments was detected by HPLC-MS/MS
Measured: baseline (before treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start1 Jul 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (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 Zhujiang HospitalThe 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
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- He Xiaolong, Professor, Study director, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379412
- Sponsor's protocol ID
- Zhujianghmy
- Status last verified
- Apr 2024
- First submitted
- 18 Apr 2024
- Last updated
- 26 Apr 2024
- 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 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study on the Association of Peptidoglycan Fragments Derived From Gut Microbiota With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06379412
- Acronym / sponsor ID
- Zhujianghmy
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Apr 2024 (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.
The goal of this observational study is to explore the association of peptidoglycan fragments derived from gut microbiota with colorectal cancer (CRC). The main question it aims to answer is: Are peptidoglycan fragments from the gut microbiota associated with the progression of colorectal cancer? Participants will provide biological specimens (blood, feces, colon tissue obtained during surgery)
Detailed description
To explore whether peptidoglycan fragments can be used as screening or diagnostic indicators for colorectal cancer
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Colorectal Cancer(CRC) | – | Other: observational study, no interventionPeople who are diagnosed with CRC by colonoscopy and pathological biopsy |
| Colorectal adenoma(CRA) | – | Other: observational study, no interventionPeople who are diagnosed with CRA by colonoscopy and pathological biopsy |
| Colorectal polyp(CRP) | – | Other: observational study, no interventionPeople who are diagnosed with CRP by colonoscopy and pathological biopsy |
| Healthy | – | Other: observational study, no interventionPeople who have no obvious abnormality in the whole colon |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Meet eligibility criteria
Key inclusion criteria (2 listed)
- People who underwent total colonoscopy in gastroenteroscopy room.
- People who agree to participate in this study and are willing to sign informed consent.
Key exclusion criteria (3 listed)
- Previous diagnosis of malignant tumors other than colorectal cancer.
- Received any of the following drug treatments within 1 month before sample collection: ① Drugs used for the treatment of colorectal diseases; ② Antibiotics; ③probiotics; ④ Laxatives.
- Patients with a family history of colorectal cancer.
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 |
|---|---|---|
| observational study, no interventionobservational study, no intervention | Other | Colorectal Cancer(CRC), Colorectal adenoma(CRA), Colorectal polyp(CRP), Healthy |
Primary outcome
HPLC-MS/MS was used to detect peptidoglycan fragment content in biological specimens of 200 participants
Time frame: baseline (before treatment)
The content of peptidoglycan fragments was detected by HPLC-MS/MS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
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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.
He Xiaolong, Professor study director
Southern Medical University, China
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, 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 2 inclusion and 3 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 26 Apr 2024. 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 Hu Mengyao (1587088392, 1377549166@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPLC-MS/MS was used to detect peptidoglycan fragment content in biological specimens of 200 participants (time frame: baseline (before treatment)). 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 26 Apr 2024.