NCT05205187

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

February 28, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 25, 2022

Status Verified

January 1, 2022

Enrollment Period

1.8 years

First QC Date

January 11, 2022

Last Update Submit

January 11, 2022

Conditions

Stomach NeoplasmsGut MicrobiotaMetabolomics

Outcome Measures

Primary Outcomes (5)

  • Participants' characteristics

    To obtain participants' characteristics, including age, gender, alcohol consumption, body mass index, smoking, medications.

    1 day

  • Microbial community structure

    To assess participants' microbiome composition in faecal samples, inclding microbial diversity and richness.

    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.

    1 day

  • Microbes-metabolites correlations

    To assess the correlations of gut microbiota and metabolites by Spearman's correlation analysis.

    1 day

  • Response of target organ

    To find the effects of microflora and metabolites on target organ by transcriptome sequencing.

    1 day

Study Arms (3)

Healthy group

Healthy people in the community.

Procedure: Healthy control specimen collection

Non-Borrmann IV group

Patients with Borrmann types I, II and III gastric cancer.

Procedure: Non-Borrmann IV patient specimen collection

Borrmann IV group

Patients with Borrmann type IV gastric cancer.

Procedure: Borrmann IV patient specimen collection

Interventions

Healthy control specimen collectionPROCEDURE

Collecting blood and feces from healthy population.

Healthy group
Non-Borrmann IV patient specimen collectionPROCEDURE

Collecting blood, feces and gastric cancer tissues from Non-Borrmann IV patients.

Non-Borrmann IV group
Borrmann IV patient specimen collectionPROCEDURE

Collecting blood, feces and gastric cancer tissues from Borrmann IV patients.

Borrmann IV group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

The fourth People's Hospital of Changzhou

Changzhou, Jiangsu, 213001, China

RECRUITING

Chaoyang Central Hospital

Chaoyang, Liaoning, 122099, China

RECRUITING

The General Hospital of Fushun Mining Bureau

Fushun, Liaoning, 113012, China

ENROLLING BY INVITATION

First Hospital of Jinzhou Medical University

Jinzhou, Liaoning, 121012, China

RECRUITING

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110000, China

ACTIVE NOT RECRUITING

The Second Hospital of Shandong University

Ji'nan, Shandong, 250033, China

ENROLLING BY INVITATION

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Kai Li, MD

    First Hospital of China Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai Li, MD

CONTACT

8613998245233cmu1h_likai@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of surgical Oncology

Study Record Dates

First Submitted

January 11, 2022

First Posted

January 25, 2022

Study Start

February 28, 2022

Primary Completion

January 1, 2024

Study Completion

December 31, 2025

Last Updated

January 25, 2022

Record last verified: 2022-01

Locations

CN(6)