Stomach NeoplasmsMBSNCT05205187
Gut Microbiota and Metabonomics
An observational study of Stomach Neoplasms and Gut Microbiota, run by First Hospital of China Medical University at 6 sites in China.
Trial summary
To evaluate the correlation between gut microbiota and metabolites in Borrmann type IV gastric cancer; To find the effects of microflora and metabolites on target organs; To detect the mechanism of key flora and metabolite by in vitro and in vivo experiments; To construct models of gut microbiota and metabonomics by… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stomach Neoplasms, Gut Microbiota, Metabolomics
- What is being tested?
- Non-Borrmann IV patient specimen collection and Borrmann IV patient specimen collection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 450 participants
- Where
- 6 sitesChina
- Study dates
- 28 Feb 2022to 31 Dec 2025
- How long will I take part?
- 5 Years
- 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: Healthy population will be selected from community samples. Non-Borrmann IV and Borrmann IV patients will be selected from Department of Oncology in hospitals.
Who may be able to join
- Patients who sign informed consent.
- Borrmann classification of gastric cancer is determined by more than 2 pathologists.
- Patients with BMI 24-28.
- Karnofsky (KPS) score >80.
Who cannot join
- Patients who take any aspirin, antibiotics, prebiotics, or probiotics within 4 weeks and steroids or immunosuppressants within 6 months prior to specimen collection.
- Patients who complicate with other malignant tumors.
- Patients who complicate with diabetes, hypertension, heart disease and infectious diseases.
- Patients who complicate with inflammatory bowel disease or irritable bowel syndrome.
- Patients with metastasis.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 5 recruiting
- Recruiting
The fourth People's Hospital of Changzhou
Changzhou, Jiangsu, 213001
Yan Li
- Recruiting
Chaoyang Central Hospital
Chaoyang, Liaoning, 122099
Shigang Guo
- Enrolling by invitation
The General Hospital of Fushun Mining Bureau
Fushun, Liaoning, 113012
- Enrolling by invitation
The Second Hospital of Shandong University
Ji'nan, Shandong, 250033
- Recruiting
First Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121012
Yubin Wang
- Active, not recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110000
About this study
Official title: Multi-center and Multi-omics Mechanism Research of Gut Microbiota and Metabonomics in Borrmann Type IV Gastric Cancer
To evaluate the correlation between gut microbiota and metabolites in Borrmann type IV gastric cancer; To find the effects of microflora and metabolites on target organs; To detect the mechanism of key flora and metabolite by in vitro and in vivo experiments; To construct models of gut microbiota and metabonomics by machine learning.
- Conditions
- Stomach Neoplasms, Gut Microbiota, Metabolomics
- Being tested
- Healthy control specimen collection, Non-Borrmann IV patient specimen collection, Borrmann IV patient specimen collection
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy control specimen collectionProcedure or surgery
Collecting blood and feces from healthy population.
Non-Borrmann IV patient specimen collectionProcedure or surgery
Collecting blood, feces and gastric cancer tissues from Non-Borrmann IV patients.
Borrmann IV patient specimen collectionProcedure or surgery
Collecting blood, feces and gastric cancer tissues from Borrmann IV patients.
| Study group | Role | What they receive |
|---|---|---|
| Healthy group | Healthy people in the community. Receives: Procedure: Healthy control specimen collection | |
| Non-Borrmann IV group | Patients with Borrmann types I, II and III gastric cancer. Receives: Procedure: Non-Borrmann IV patient specimen collection | |
| Borrmann IV group | Patients with Borrmann type IV gastric cancer. Receives: Procedure: Borrmann IV patient specimen collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' characteristics
To obtain participants' characteristics, including age, gender, alcohol consumption, body mass index, smoking, medications.
Measured: 1 day
Microbial community structure
To assess participants' microbiome composition in faecal samples, inclding microbial diversity and richness.
Measured: 1 day
Metabolite composition
To measure the metabolite profiles in participants' faecal samples and serum samples, involving Bile acids, short chain fatty acids, TMAO and related metabolites, amino acids, fatty acids, organic acids, flavonoids, plant hormones, neurotransmitters.
Measured: 1 day
Microbes-metabolites correlations
To assess the correlations of gut microbiota and metabolites by Spearman's correlation analysis.
Measured: 1 day
Response of target organ
To find the effects of microflora and metabolites on target organ by transcriptome sequencing.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start28 Feb 2022 (estimated)
- Primary completion1 Jan 2024 (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 Stomach NeoplasmsStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- First Hospital of China Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Liaoning Cancer Hospital & Institute, The Second Hospital of Shandong University, The General Hospital of Fushun Mining Bureau, The fourth People's Hospital of Changzhou, The First People's Hospital of Jingzhou
- Responsible party
- Principal investigator, Kai Li, First Hospital of China Medical University
- Investigators
- Kai Li, MD, Principal investigator, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205187
- Sponsor's protocol ID
- Metabonomics
- Acronym
- MBS
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2022
- Last updated
- 25 Jan 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 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center and Multi-omics Mechanism Research of Gut Microbiota and Metabonomics in Borrmann Type IV Gastric Cancer
- ClinicalTrials.gov ID
- NCT05205187
- Acronym / sponsor ID
- MBS / Metabonomics
- Conditions
- Stomach Neoplasms, Gut Microbiota, Metabolomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- First Hospital of China Medical UniversityUniversity, hospital or other
- Collaborators
- Liaoning Cancer Hospital & Institute, The Second Hospital of Shandong University, The General Hospital of Fushun Mining Bureau, The fourth People's Hospital of Changzhou, The First People's Hospital of Jingzhou
- Study start
- 28 Feb 2022 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Jan 2022 (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.
To evaluate the correlation between gut microbiota and metabolites in Borrmann type IV gastric cancer; To find the effects of microflora and metabolites on target organs; To detect the mechanism of key flora and metabolite by in vitro and in vivo experiments; To construct models of gut microbiota and metabonomics by machine learning.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy group | – | Procedure: Healthy control specimen collectionHealthy people in the community. |
| Non-Borrmann IV group | – | Procedure: Non-Borrmann IV patient specimen collectionPatients with Borrmann types I, II and III gastric cancer. |
| Borrmann IV group | – | Procedure: Borrmann IV patient specimen collectionPatients with Borrmann type IV gastric cancer. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy population will be selected from community samples. Non-Borrmann IV and Borrmann IV patients will be selected from Department of Oncology in hospitals.
Key inclusion criteria (4 listed)
- Patients who sign informed consent.
- Borrmann classification of gastric cancer is determined by more than 2 pathologists.
- Patients with BMI 24-28.
- Karnofsky (KPS) score >80.
Key exclusion criteria (5 listed)
- Patients who take any aspirin, antibiotics, prebiotics, or probiotics within 4 weeks and steroids or immunosuppressants within 6 months prior to specimen collection.
- Patients who complicate with other malignant tumors.
- Patients who complicate with diabetes, hypertension, heart disease and infectious diseases.
- Patients who complicate with inflammatory bowel disease or irritable bowel syndrome.
- Patients with metastasis.
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 |
|---|---|---|
| Healthy control specimen collectionCollecting blood and feces from healthy population. | Procedure or surgery | Healthy group |
| Non-Borrmann IV patient specimen collectionCollecting blood, feces and gastric cancer tissues from Non-Borrmann IV patients. | Procedure or surgery | Non-Borrmann IV group |
| Borrmann IV patient specimen collectionCollecting blood, feces and gastric cancer tissues from Borrmann IV patients. | Procedure or surgery | Borrmann IV group |
Primary outcome
Participants' characteristics
Time frame: 1 day
To obtain participants' characteristics, including age, gender, alcohol consumption, body mass index, smoking, medications.
Microbial community structure
Time frame: 1 day
To assess participants' microbiome composition in faecal samples, inclding microbial diversity and richness.
Metabolite composition
Time frame: 1 day
To measure the metabolite profiles in participants' faecal samples and serum samples, involving Bile acids, short chain fatty acids, TMAO and related metabolites, amino acids, fatty acids, organic acids, flavonoids, plant hormones, neurotransmitters.
Microbes-metabolites correlations
Time frame: 1 day
To assess the correlations of gut microbiota and metabolites by Spearman's correlation analysis.
Response of target organ
Time frame: 1 day
To find the effects of microflora and metabolites on target organ by transcriptome sequencing.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
Related trials for Stomach Neoplasms
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
Not yet recruitingPhase 2
Serplulimab, DOS and Lenvatinib Combine With PIPAC in the Oligometastatic Peritoneal Metastasis of Gastric/Gastroesophageal Junction Adenocarcinoma
Gastric/Gastroesophageal Junction Adenocarcinoma, Oligometastatic Peritoneal Metastasis
Not yet recruitingPhase 2
Application of Intraperitoneal Hyperthermic Chemotherapy in the Treatment of Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (Diagnosis)
Not yet recruitingObservational study
Lymph Node Dissection After Neoadjuvant Therapy for Gastric and EGJ Adenocarcinoma
Gastric Adenocarcinoma, Esophagogastric Junction Adenocarcinoma
RecruitingPhase 2
Non-covalent BTK Inhibitor Nemtabrutinib in Combination With the CD20 Monoclonal Antibody Rituximab for the Treatment of Marginal Zone Lymphoma
Conjunctival Mucosa-Associated Lymphoid Tissue Lymphoma, Gastric Mucosa-Associated Lymphoid Tissue Lymphoma
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.
Kai Li, MD principal investigator
First Hospital of China Medical University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stomach Neoplasms and Gut Microbiota, run by First Hospital of China Medical University at 6 sites 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 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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 Kai Li, MD (8613998245233, cmu1h_likai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' characteristics (time frame: 1 day). The study lists 5 primary outcomes in all. 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 25 Jan 2022.