Microbiome Analysis in Gastric Intestinal Metaplasia and in Gastric Cancer and Subtypes Correlation

NCT04365946 | Unknown DMC

• 1 other identifier: 1
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study will be to analyze the microbiome in the blood and stomach in patients with intestinal metaplasia (IM) and / or gastric cancer (GC). As far as IM is concerned, it has been found that the incomplete type is related to GC mainly intestinal-type. Studies show differences in the microbiome in patients with IM and in patients with GC, but do not specify whether these differences are related to histological types. Our intention is to further analyze the microbiome based on histological types. Most studies on stomach cancer have focused on the microbiota of gastric microbiota. Recent data have shown that the microbiome of the small intestine, especially the mucosa, can play a key role in the condition of the gastrointestinal tract. Disturbance of the microbiome of the small intestine has been found in celiac disease, chronic liver disease, diabetes and irritable bowel syndrome. However, information on the role of the microbiome in IM remains limited.

Conditions

Gastric Intestinal Metaplasia; Gastric Cancer; Microbiome

Keywords

Gastric intestinal metaplasia; Gastric cancer; Subtypes; Microbiome

Outcome Measures

Primary Outcomes (2)

• Analysis of microbiome in subtypes of intestinal metaplasia and gastric cancer

  Microbiome analysis with complete and incomplete type of intestinal metaplasia and subtypes of gastric cancer

  Through study completion, an average of 1 year.

• Analysis of microbiome in subtypes of intestinal metaplasia and gastric cancer

  Microbiome correlation with complete and incomplete type of intestinal metaplasia and subtypes of gastric cancer

  Through study completion, an average of 1 year.

Study Arms (3)

Complete type

Patients with complete-type intestinal metaplasia

Procedure: Gastroscopy

Incomplete type

Patients with incomplete-type intestinal metaplasia

Procedure: Gastroscopy

Controls

Healthy subjects

Procedure: Gastroscopy

Interventions

Gastroscopy PROCEDURE

Upper GI endoscopy and biopsy

Complete type; Controls; Incomplete type

Eligibility Criteria

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

Study Population

Patients with gastric intestinal metaplasia and/or gastric cancer, and healthy controls

You may qualify if:

• Patients with gastric intestinal metaplasia and/or gastric cancer
• Healthy controls

You may not qualify if:

• Metabolic syndrome and its components
• IBD
• Autoimmune diseases
• Otherwise tumours

Sponsors & Collaborators

• University Hospital, Ioannina: lead
• University of Ioannina: collaborator

Study Sites (1)

University Hospital of Ioannina

Ioannina, 45500, Greece

Location

Related Publications (11)

• Gao JJ, Zhang Y, Gerhard M, Mejias-Luque R, Zhang L, Vieth M, Ma JL, Bajbouj M, Suchanek S, Liu WD, Ulm K, Quante M, Li ZX, Zhou T, Schmid R, Classen M, Li WQ, You WC, Pan KF. Association Between Gut Microbiota and Helicobacter pylori-Related Gastric Lesions in a High-Risk Population of Gastric Cancer. Front Cell Infect Microbiol. 2018 Jun 19;8:202. doi: 10.3389/fcimb.2018.00202. eCollection 2018.

  PMID: 29971220 BACKGROUND

• Liu X, Shao L, Liu X, Ji F, Mei Y, Cheng Y, Liu F, Yan C, Li L, Ling Z. Alterations of gastric mucosal microbiota across different stomach microhabitats in a cohort of 276 patients with gastric cancer. EBioMedicine. 2019 Feb;40:336-348. doi: 10.1016/j.ebiom.2018.12.034. Epub 2018 Dec 21.

  PMID: 30584008 BACKGROUND

• Wang L, Zhou J, Xin Y, Geng C, Tian Z, Yu X, Dong Q. Bacterial overgrowth and diversification of microbiota in gastric cancer. Eur J Gastroenterol Hepatol. 2016 Mar;28(3):261-6. doi: 10.1097/MEG.0000000000000542.

  PMID: 26657453 BACKGROUND

• Gong J, Li L, Zuo X, Li Y. Change of the duodenal mucosa-associated microbiota is related to intestinal metaplasia. BMC Microbiol. 2019 Dec 9;19(1):275. doi: 10.1186/s12866-019-1666-5.

  PMID: 31815623 BACKGROUND

• Eun CS, Kim BK, Han DS, Kim SY, Kim KM, Choi BY, Song KS, Kim YS, Kim JF. Differences in gastric mucosal microbiota profiling in patients with chronic gastritis, intestinal metaplasia, and gastric cancer using pyrosequencing methods. Helicobacter. 2014 Dec;19(6):407-16. doi: 10.1111/hel.12145. Epub 2014 Jul 23.

  PMID: 25052961 BACKGROUND

• Park CH, Lee AR, Lee YR, Eun CS, Lee SK, Han DS. Evaluation of gastric microbiome and metagenomic function in patients with intestinal metaplasia using 16S rRNA gene sequencing. Helicobacter. 2019 Feb;24(1):e12547. doi: 10.1111/hel.12547. Epub 2018 Nov 15.

  PMID: 30440093 BACKGROUND

• Hsieh YY, Tung SY, Pan HY, Yen CW, Xu HW, Lin YJ, Deng YF, Hsu WT, Wu CS, Li C. Increased Abundance of Clostridium and Fusobacterium in Gastric Microbiota of Patients with Gastric Cancer in Taiwan. Sci Rep. 2018 Jan 9;8(1):158. doi: 10.1038/s41598-017-18596-0.

  PMID: 29317709 BACKGROUND

• Park CH, Lee JG, Lee AR, Eun CS, Han DS. Network construction of gastric microbiome and organization of microbial modules associated with gastric carcinogenesis. Sci Rep. 2019 Aug 27;9(1):12444. doi: 10.1038/s41598-019-48925-4.

  PMID: 31455798 BACKGROUND

• Jencks DS, Adam JD, Borum ML, Koh JM, Stephen S, Doman DB. Overview of Current Concepts in Gastric Intestinal Metaplasia and Gastric Cancer. Gastroenterol Hepatol (N Y). 2018 Feb;14(2):92-101.

  PMID: 29606921 BACKGROUND

• Schulz C, Schutte K, Mayerle J, Malfertheiner P. The role of the gastric bacterial microbiome in gastric cancer: Helicobacter pylori and beyond. Therap Adv Gastroenterol. 2019 Dec 18;12:1756284819894062. doi: 10.1177/1756284819894062. eCollection 2019.

  PMID: 31897087 BACKGROUND

• Cui J, Cui H, Yang M, Du S, Li J, Li Y, Liu L, Zhang X, Li S. Tongue coating microbiome as a potential biomarker for gastritis including precancerous cascade. Protein Cell. 2019 Jul;10(7):496-509. doi: 10.1007/s13238-018-0596-6. Epub 2018 Nov 26.

  PMID: 30478535 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood Tissue

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Gastroscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Konstantinos Vlachos, Prof

  University of Ioannina

  STUDY DIRECTOR

• George Pappas-Gogos, Dr

  University Hospital, Ioannina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: George Pappas-Gogos, Principal Investigator

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 28, 2020
• Study Start: April 18, 2020
• Primary Completion: September 14, 2020
• Study Completion: May 15, 2023
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2021-2023
• Access Criteria: Researchers who would access data, statistics and results of this study in order to perform similar studies

Locations

GR (1)