Gastric Cancer Clinical Trial
Official title:
Microbiome Analysis in Patients With Gastric Intestinal Metaplasia and in Patients With Gastric Cancer and Correlation With the Subtypes of the Lesions
NCT number | NCT04365946 |
Other study ID # | 1 |
Secondary ID | |
Status | Active, not recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 18, 2020 |
Est. completion date | May 15, 2023 |
Verified date | April 2020 |
Source | University Hospital, Ioannina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | May 15, 2023 |
Est. primary completion date | September 14, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patients with gastric intestinal metaplasia and/or gastric cancer - Healthy controls Exclusion Criteria: - Metabolic syndrome and its components - IBD - Autoimmune diseases - Otherwise tumours |
Country | Name | City | State |
---|---|---|---|
Greece | University Hospital of Ioannina | Ioánnina |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ioannina | University of Ioannina |
Greece,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Schulz C, Schütte 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. Review. — View Citation
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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. |
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