Associations Among Serum and Gastric Juice Bile Acid Profile, Bile Acid-microbiota Cross-talk in Stomach and the Development of Gastric Cancer

NCT04660058 | Completed

• 1 other identifier: KY20202100-F-1
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the associations among bile acid profile, bile acid-microbiota cross-talk and the development of gastric cancer, so as to better prevent the occurrence and development of gastric cancer

Conditions

Bile Reflux; Gastric Cancer; Precancerous Lesion

Keywords

bile acid; gastric microbiota; Gastric Cancer; precancerous lesion

Outcome Measures

Primary Outcomes (2)

• corelation between the bile acid profile and gastric mucosa diseases

  Investigators evaluate the corelation between the bile acid profile and gastric mucosa diseases according to the results of UPLC-MS/MS and pathological .

  up to 6 months

• corelation between the bile acid profile and gastric microbiota in different groups

  Investigators explore the cross-talk between bile acid and gastric microbiota according to the results of 16s rRNA sequencing

  up to 6 months

Study Arms (3)

chronic gastritis

patients with chronic non-atrophic gastritis and chronic atrophic gastritis according to histopathological results

precancerous lesion

patients with gastric intestinal metaplasia and intraepithelial neoplasia according to histopathological results

gastric cancer

patients with gastric cancer according to histopathological results

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients are from Xijing Hospital

You may qualify if:

• Age 18 to 75 years old, gender is not limited;
• No history of antibiotic or probiotic use for 8 weeks;
• No preoperative chemotherapy or radiation therapy prior to the examination;
• Voluntary intravenous blood collection, gastroscopy, extraction of gastric juice and pathological biopsy.
• Voluntary testing for H. pylori

You may not qualify if:

• had undergone upper gastrointestinal and colon surgery;
• Previous diagnosis of Malignant Tumors;
• Presence of a disease or medication that affects bile acid metabolism, such as endocrine or autoimmune diseases;
• Recent use of drugs that affect gastrointestinal motility;
• Presence of contraindications to endoscopy;
• pregnant and lactating women;
• Those with mental disorders;
• Refusal to sign the informed consent form.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710032, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum and gastric juice samples will not be retained; pathological tissue samples will be retained in Xijing Hospital

MeSH Terms

Conditions

Bile Reflux; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Duodenogastric Reflux; Stomach Diseases; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 9, 2020
• Study Start: December 20, 2020
• Primary Completion: December 30, 2021
• Study Completion: January 30, 2022
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

CN (1)