NCT06079554

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

October 6, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

March 31, 2024

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

28 days

First QC Date

October 6, 2023

Last Update Submit

April 11, 2024

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Metabolomics results of lesions and atrophic gastritis.

    liquid chromatograph mass spectrometer metabolic profling

    1year

Secondary Outcomes (1)

  • microbiomics of lesions and atrophic gastritis.

    1 year

Other Outcomes (2)

  • degree of gastric atrophy,

    1year

  • endoscopic observation

    1year

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We underwent magnifying staining endoscopy examination in our hospital and diagnosed cases of atrophic gastritis with or without gastric cancer under endoscopy.

You may qualify if:

  • Intestinal type of gastric cancer or atrophic gastritis
  • Underwent Endoscopic submucosal dissection（ESD）

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Hong Xu, professor

CONTACT

1884409766818844097668@163.com

Dong Yang, doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisted Investigator

Study Record Dates

First Submitted

October 6, 2023

First Posted

October 12, 2023

Study Start

March 31, 2024

Primary Completion

April 28, 2024

Study Completion

August 30, 2025

Last Updated

April 12, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)