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Microbiota and Metabolomics of Intestinal Type of Gastric Cancer

Sponsor
Jilin University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06079554
Collaborator
(none)
32
Enrollment
1
Location
22
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Compare with the gastric cavity without cancerous transformation in atrophic gastritis, analyze the microbiota and metabolomics changes in intestinal type of gastric cancer under the background of atrophic gastritis, and explore the relevant mechanisms.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study adopts a prospective cohort study. The expected recruitment time for all participants is 6 months, and all cases are cases who would receive magnifying endoscopy examination. The extent of atrophy and the presence of early gastric cancer are determined under magnifying endoscopy. Cases are chose into the gastric cancer group and atrophic gastritis group in a 1:1 ratio. There are 16 cases of intestinal type of gastric cancer under the background of atrophic gastritis, and 16 cases of atrophic gastritis without gastric cancer matched according to gender, age, and degree of gastric atrophy, totaling 32 cases. Analyze the characteristics of early gastric cancer under endoscopy, investigate the changes in microbiota and metabolomics of intestinal type of gastric cancer under the background of atrophic gastritis, and explore the relevant mechanisms.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    32 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Microbiota and Metabolomics of Intestinal Type of Gastric Cancer in the Context of Atrophic Gastritis
    Anticipated Study Start Date :
    Oct 31, 2023
    Anticipated Primary Completion Date :
    Apr 28, 2024
    Anticipated Study Completion Date :
    Aug 30, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    the gastric cancer group

    16 cases of intestinal type of gastric cancer under the background of atrophic gastritis
    the atrophic gastritis group

    16 cases of atrophic gastritis without gastric cancer matched according to gender, age, and degree of gastric atrophy

    Outcome Measures

    Primary Outcome Measures

    1. Metabolomics results of lesions and atrophic gastritis. [1year]

      liquid chromatograph mass spectrometer metabolic profling

    Secondary Outcome Measures

    1. microbiomics of lesions and atrophic gastritis. [1 year]

      16SrRNA analysis

    Other Outcome Measures

    1. degree of gastric atrophy, [1year]

      According to the classification of Kimura-Takemoto Classification （C1-O3）

    2. endoscopic observation [1year]

      NBI observation of atrophic background color, surrounding color of the lesion, lesion color, presence or absence of boundary transition zones, scattered intact glands within the lesion,presence of incomplete mesh patterns, and presence or absence of other early gastric cancer endoscopic manifestations.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • •Intestinal type of gastric cancer or atrophic gastritis

    • Underwent Endoscopic submucosal dissection（ESD）

    Exclusion Criteria:

    • • have simultaneously other cancer

    • have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 the First Hospital of Jilin University Chang chun Ji Lin China 130021

    Sponsors and Collaborators

    • Jilin University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dong Yang, Assisted Investigator, Jilin University
    ClinicalTrials.gov Identifier:
    NCT06079554
    Other Study ID Numbers:
    • 130027
    First Posted:
    Oct 12, 2023
    Last Update Posted:
    Oct 12, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Stomach Neoplasms

    Study Results

    No Results Posted as of Oct 12, 2023