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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05205187
Other study ID # Metabonomics
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 28, 2022
Est. completion date December 31, 2025

Study information

Verified date January 2022
Source First Hospital of China Medical University
Contact Kai Li, MD
Phone 8613998245233
Email cmu1h_likai@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 machine learning.


Recruitment information / eligibility

Status Recruiting
Enrollment 450
Est. completion date December 31, 2025
Est. primary completion date January 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. Patients who sign informed consent. 2. Borrmann classification of gastric cancer is determined by more than 2 pathologists. 3. Patients with BMI 24-28. 4. Karnofsky (KPS) score >80. Exclusion Criteria: 1. Patients who take any aspirin, antibiotics, prebiotics, or probiotics within 4 weeks and steroids or immunosuppressants within 6 months prior to specimen collection. 2. Patients who complicate with other malignant tumors. 3. Patients who complicate with diabetes, hypertension, heart disease and infectious diseases. 4. Patients who complicate with inflammatory bowel disease or irritable bowel syndrome. 5. Patients with metastasis.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Healthy control specimen collection
Collecting blood and feces from healthy population.
Non-Borrmann IV patient specimen collection
Collecting blood, feces and gastric cancer tissues from Non-Borrmann IV patients.
Borrmann IV patient specimen collection
Collecting blood, feces and gastric cancer tissues from Borrmann IV patients.

Locations

Country Name City State
China The fourth People's Hospital of Changzhou Changzhou Jiangsu
China Chaoyang Central Hospital Chaoyang Liaoning
China The General Hospital of Fushun Mining Bureau Fushun Liaoning
China The Second Hospital of Shandong University Ji'nan Shandong
China First Hospital of Jinzhou Medical University Jinzhou Liaoning
China The First Affiliated Hospital of China Medical University Shenyang Liaoning

Sponsors (6)

Lead Sponsor Collaborator
First Hospital of China Medical University Liaoning Cancer Hospital & Institute, The First People's Hospital of Jingzhou, The fourth People's Hospital of Changzhou, The General Hospital of Fushun Mining Bureau, The Second Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Participants' characteristics To obtain participants' characteristics, including age, gender, alcohol consumption, body mass index, smoking, medications. 1 day
Primary Microbial community structure To assess participants' microbiome composition in faecal samples, inclding microbial diversity and richness. 1 day
Primary 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. 1 day
Primary Microbes-metabolites correlations To assess the correlations of gut microbiota and metabolites by Spearman's correlation analysis. 1 day
Primary Response of target organ To find the effects of microflora and metabolites on target organ by transcriptome sequencing. 1 day
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