Microbiota and Metabolomics of Intestinal Type of Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

Microbiota and Metabolomics of Intestinal Type of Gastric Cancer in the Context of Atrophic Gastritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06079554
• Other study ID #: 130027
• Status: Recruiting
• Start date: March 31, 2024
• Est. completion date: August 30, 2025

Study information

• Verified date: April 2024
• Source: Jilin University
• Contact: Hong Xu, professor
• Phone: 18844097668
• Email: 18844097668[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: August 30, 2025
• Est. primary completion date: April 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
China	the First Hospital of Jilin University	Chang chun	Ji Lin

Sponsors (1)

Lead Sponsor	Collaborator
Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	degree of gastric atrophy,	According to the classification of Kimura-Takemoto Classification (C1-O3)	1year
Other	endoscopic observation	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.	1year
Primary	Metabolomics results of lesions and atrophic gastritis.	liquid chromatograph mass spectrometer metabolic profling	1year
Secondary	microbiomics of lesions and atrophic gastritis.	16SrRNA analysis	1 year