UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061932 |
|---|---|
| Receipt number | R000070868 |
| Scientific Title | A prospective observational study to evaluate the association between gastric mucosal atrophy, upper gastrointestinal microbiota, and esophageal squamous neoplasia |
| Date of disclosure of the study information | 2026/06/16 |
| Last modified on | 2026/06/16 20:19:27 |
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Basic information
Public title
Association of gastric mucosal atrophy and upper gastrointestinal microbiota with esophageal squamous neoplasia: a prospective observational study
Acronym
GAMES Study (Gastric Atrophy and Microbiota in Esophageal Squamous neoplasia)
Scientific Title
A prospective observational study to evaluate the association between gastric mucosal atrophy, upper gastrointestinal microbiota, and esophageal squamous neoplasia
Scientific Title:Acronym
GAMES Study (Gastric Atrophy and Microbiota in Esophageal Squamous neoplasia)
Region
| Japan |
Condition
Condition
Esophageal squamous neoplasia (esophageal squamous cell carcinoma and high-grade intraepithelial neoplasia)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The objective of this study is to investigate the association of gastric mucosal atrophy and upper gastrointestinal microbiota with esophageal squamous neoplasia. In particular, this study aims to prospectively evaluate how the degree of gastric mucosal atrophy and structural characteristics of the esophageal microbiota are associated with the presence of esophageal squamous neoplasia.
Basic objectives2
Others
Basic objectives -Others
To investigate disease-related associations in an observational setting
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Association of the degree of gastric mucosal atrophy and structural characteristics of the esophageal microbiota with the presence of esophageal squamous neoplasia
Key secondary outcomes
-Association between gastric mucosal atrophy and structural characteristics of the esophageal microbiota
-Association between gastric mucosal atrophy and esophageal squamous neoplasia mediated by the esophageal microbiota
-Differences in the composition of the esophageal microbiota in relation to gastric mucosal atrophy
-Association between salivary microbiota and upper gastrointestinal microbiota (exploratory analysis)
-Association of clinical background factors and genetic factors with gastric mucosal atrophy, esophageal microbiota, and esophageal squamous neoplasia
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Adults aged 18 years or older
-Individuals undergoing clinically indicated upper gastrointestinal endoscopy
-Participants who meet one of the following criteria:
(i) Patients with newly diagnosed superficial esophageal squamous neoplasia (esophageal squamous cell carcinoma or high-grade intraepithelial neoplasia)
(ii) Control patients without esophageal squamous neoplasia
-Provision of written informed consent
Key exclusion criteria
-Patients with advanced esophageal cancer
-History of esophageal squamous neoplasia
-Patients with esophageal obstruction
-Receipt of chemotherapy or radiotherapy within 6 months
-Use of antibiotics within 8 weeks
-Initiation or dose change of acid-suppressive medications or probiotics within 8 weeks
-Participants judged to be ineligible by the investigator
-Lack of or withdrawal of informed consent
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Kenta |
| Middle name | |
| Last name | Watanabe |
Organization
Akita University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
010-8543
Address
1-1-1 Hondo, Akita, Akita 010-8543, Japan
TEL
+81-18-884-6104
nabeken@med.akita-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Watanabe |
Organization
Akita University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
010-8543
Address
1-1-1 Hondo, Akita, Akita 010-8543, Japan
TEL
+81-18-884-6104
Homepage URL
nabeken@med.akita-u.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Akita University Graduate School of Medicine and Faculty of Medicine
Address
1-1-1 Hondo, Akita, Akita 010-8543, Japan
Tel
+81-18-884-6461
soken@hos.akita-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational study in which participants are consecutively enrolled. During clinically indicated upper gastrointestinal endoscopy, esophageal and gastric mucosal brush samples as well as saliva samples are collected for microbiome analysis. No therapeutic intervention is performed, and the collected biological samples and clinical data are used to evaluate the association between gastric mucosal atrophy, upper gastrointestinal microbiota, and esophageal squamous neoplasia.
Management information
Registered date
| 2026 | Year | 06 | Month | 16 | Day |
Last modified on
| 2026 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070868
