Colorectal CancerNCT04924686
Changes of Muramyl Dipeptide in Intestinal and Extra-intestinal Diseases
An observational study of Colorectal Cancer and Inflammatory Bowel Disease, run by Zhujiang Hospital at 1 site in China.
Trial summary
Nucleotide-binding oligomerization domain 2 (Nod2) signaling is critical for human health.To figure out the clinical relevance of NOD2 ligands, the investigators plan to evaluate the change of NOD2 ligands in inflammatory bowel diseases (IBD), CRC, atherosclerotic cardiovascular disease (ACVD), and type 2 diabetes… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Inflammatory Bowel Disease, Atherosclerotic Cardiovascular Disease
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 10 May 2020to 15 Aug 2023
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All the patients with IBD, CRC, ACVD or DM2 hospitalized in Zhujiang hospital will be eligible to be enrolled. Also, their age- and sex- matched healthy controls making a physical examination in Zhujiang hospital will be eligible to be enrolled
Who may be able to join
- Males or females at least 18-70 years old.
- Patient able to give informed consent.
- Patient with biopsy-proven CRC
- Patient with biopsy-proven Crohn's disease (CD) or ulcerative colitis(UC), in the active phase.
- patients with clinical diagnosed DM2
- patients with ACVD:coronary angiography more than 50% stenosis in single or multiple vessels.
- The age- and sex- matched health controls for each patient.
Who cannot join
- 1.Use antibiotics or probiotics within the last 2 weeks.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang hospital
Guangzhou, Guangdong, 510000
Zhou Hongwei, Professor, 18688489622, hzhou@smu.edu.cn
About this study
Official title: A Bacterial Bi-functional Peptidoglycan Hydrolase Sheds NOD2 Ligands to Regulate Gut Homeostasis
Nucleotide-binding oligomerization domain 2 (Nod2) signaling is critical for human health.To figure out the clinical relevance of NOD2 ligands, the investigators plan to evaluate the change of NOD2 ligands in inflammatory bowel diseases (IBD), CRC, atherosclerotic cardiovascular disease (ACVD), and type 2 diabetes mellitus (DM2 ).
Read the detailed description
Previous studies have shown that NOD2 gene mutants were associated with the Crohn's disease (CD), colorectal cancer (CRC) and many other diseases, suggesting the critical role of NOD2 signaling in human physiology and pathogenethesis. However, whether decreased NOD2 ligands also contributed to these diseases is unknown. In this study, the investigators plan to evaluate the change of NOD2 ligands in inflammatory bowel diseases (IBD), CRC, atherosclerotic cardiovascular disease (ACVD), and type 2 diabetes mellitus (DM2 ). For each of the patient, a sex- and age- matched control were chosen. Both the targeted metabolomics (LC-MS-MS methods) and NOD2-transfected cells co-expressing NF-κB luciferase reporters were used to test NOD2 ligands in the fecal and plasma samples.
- Conditions
- Colorectal Cancer, Inflammatory Bowel Disease, Atherosclerotic Cardiovascular Disease, Type2 Diabetes Mellitus
- Being tested
- Observational studies, no intervention
- Keywords
- NOD2 ligands
- Medical subject headings
- Colorectal Neoplasms, Inflammatory Bowel Diseases, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studies, no interventionOther
Observational studies, no intervention
| Study group | Role | What they receive |
|---|---|---|
| Crohn's disease | The fecal and plasma were collected Receives: Other: Observational studies, no intervention | |
| Ulcerative colitis | The fecal and plasma were collected Receives: Other: Observational studies, no intervention | |
| Diabetes mellitus, type 2 | The fecal and plasma were collected Receives: Other: Observational studies, no intervention | |
| Atherosclerotic cardiovascular disease | The fecal and plasma were collected Receives: Other: Observational studies, no intervention | |
| Colorectal cancer | The fecal and plasma were collected Receives: Other: Observational studies, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
NOD2 ligands in fecal and plasma
detected using targeted metabolomics (LC-MS-MS methods) and NOD2-transfected cells co-expressing NF-κB luciferase reporters
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start10 May 2020
- Primary completion10 Jun 2023 (estimated)
- Study completion15 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Hongwei Zhou, Zhujiang Hospital
- Investigators
- Hongwei Zhou, professor, Principal investigator, Zhujiang Hospital, Guangzhou, Guangdong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924686
- Sponsor's protocol ID
- ZhujiangH-1
- Status last verified
- Jun 2021
- First submitted
- 7 Jun 2021
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Philpott DJ, Sorbara MT, Robertson SJ, Croitoru K, Girardin SE. NOD proteins: regulators of inflammation in health and disease. Nat Rev Immunol. 2014 Jan;14(1):9-23. doi: 10.1038/nri3565. Epub 2013 Dec 13.
PubMed 24336102
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bacterial Bi-functional Peptidoglycan Hydrolase Sheds NOD2 Ligands to Regulate Gut Homeostasis
- ClinicalTrials.gov ID
- NCT04924686
- Acronym / sponsor ID
- ZhujiangH-1
- Conditions
- Colorectal Cancer, Inflammatory Bowel Disease, Atherosclerotic Cardiovascular Disease, Type2 Diabetes Mellitus
- Keywords
- NOD2 ligands
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 10 May 2020 (actual)
- Primary completion
- 10 Jun 2023 (estimated)
- Study completion
- 15 Aug 2023 (estimated)
- First posted
- 14 Jun 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.
Nucleotide-binding oligomerization domain 2 (Nod2) signaling is critical for human health.To figure out the clinical relevance of NOD2 ligands, the investigators plan to evaluate the change of NOD2 ligands in inflammatory bowel diseases (IBD), CRC, atherosclerotic cardiovascular disease (ACVD), and type 2 diabetes mellitus (DM2 ).
Detailed description
Previous studies have shown that NOD2 gene mutants were associated with the Crohn's disease (CD), colorectal cancer (CRC) and many other diseases, suggesting the critical role of NOD2 signaling in human physiology and pathogenethesis. However, whether decreased NOD2 ligands also contributed to these diseases is unknown. In this study, the investigators plan to evaluate the change of NOD2 ligands in inflammatory bowel diseases (IBD), CRC, atherosclerotic cardiovascular disease (ACVD), and type 2 diabetes mellitus (DM2 ). For each of the patient, a sex- and age- matched control were chosen. Both the targeted metabolomics (LC-MS-MS methods) and NOD2-transfected cells co-expressing NF-κB luciferase reporters were used to test NOD2 ligands in the fecal and plasma samples.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Crohn's disease | – | Other: Observational studies, no interventionThe fecal and plasma were collected |
| Ulcerative colitis | – | Other: Observational studies, no interventionThe fecal and plasma were collected |
| Diabetes mellitus, type 2 | – | Other: Observational studies, no interventionThe fecal and plasma were collected |
| Atherosclerotic cardiovascular disease | – | Other: Observational studies, no interventionThe fecal and plasma were collected |
| Colorectal cancer | – | Other: Observational studies, no interventionThe fecal and plasma were collected |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients with IBD, CRC, ACVD or DM2 hospitalized in Zhujiang hospital will be eligible to be enrolled. Also, their age- and sex- matched healthy controls making a physical examination in Zhujiang hospital will be eligible to be enrolled
Key inclusion criteria (7 listed)
- Males or females at least 18-70 years old.
- Patient able to give informed consent.
- Patient with biopsy-proven CRC
- Patient with biopsy-proven Crohn's disease (CD) or ulcerative colitis(UC), in the active phase.
- patients with clinical diagnosed DM2
Key exclusion criteria (1 listed)
- 1.Use antibiotics or probiotics within the last 2 weeks.
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 studies, no interventionObservational studies, no intervention | Other | Atherosclerotic cardiovascular disease, Colorectal cancer, Crohn's disease, Diabetes mellitus, type 2, Ulcerative colitis |
Primary outcome
NOD2 ligands in fecal and plasma
Time frame: baseline
detected using targeted metabolomics (LC-MS-MS methods) and NOD2-transfected cells co-expressing NF-κB luciferase reporters
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Background: PubMed 24336102Philpott DJ, Sorbara MT, Robertson SJ, Croitoru K, Girardin SE. NOD proteins: regulators of inflammation in health and disease. Nat Rev Immunol. 2014 Jan;14(1):9-23. doi: 10.1038/nri3565. Epub 2013 Dec 13.
- Individual participant dataSharing planned: No
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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.
Hongwei Zhou, professor principal investigator
Zhujiang Hospital, Guangzhou, Guangdong
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 Inflammatory Bowel Disease, 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 7 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 14 Jun 2021. 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 Jie Gao, PHD (15625043043 ext. 86, 994856235@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NOD2 ligands in fecal and plasma (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04924686, which also lists 1 linked publication.
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 14 Jun 2021.