Unique ID issued by UMIN | UMIN000058331 |
---|---|
Receipt number | R000064380 |
Scientific Title | A multicenter retrospective study on gastric cancer screening considering H. pylori infection |
Date of disclosure of the study information | 2025/07/01 |
Last modified on | 2025/07/01 09:48:54 |
A multicenter retrospective study on gastric cancer screening considering H. pylori infection
A multicenter retrospective study on gastric cancer screening considering H. pylori infection
A multicenter retrospective study on gastric cancer screening considering H. pylori infection
A multicenter retrospective study on gastric cancer screening considering H. pylori infection
Japan |
gastric cancer
Gastroenterology |
Malignancy
NO
To obtain the latest data on HP eradication and gastric cancer in Japan by taking advantage of the scale of a large multicenter collaborative study to conduct the following four studies and combining them with statistical analysis.
1) To investigate the current status of gastric cancer incidence and HP infection among gastric cancer screening participants, and the current status of the spread of eradication treatment over time.
2) Verification of the effectiveness of HP eradication in reducing the incidence of gastric cancer (1-5 years, 6-10 years, 11-15 years, 16-20 years, and more than 20 years after eradication).
3) Obtain large-scale data on the characteristics of gastric cancer after HP eradication (site of occurrence, histopathologic type, and depth of disease).
(compare with gastric cancer in HP unsterilized cases and HP lifetime uninfected gastric cancer)
4) Predict the optimal recommended examination interval for early gastric cancer detection
Translated with DeepL.com (free version)
Efficacy
Association between the preventive effect of H. pylori eradication treatment and the development of gastric cancer
Specific evaluation items are planned to be as follows:
a) Annual trends in the incidence of gastric cancer and gastric adenoma (including metachronous multiple cases)
b) Annual trends in the incidence of esophageal cancer (including metachronous multiple cases)
c) Annual trends in gastric cancer, gastric adenoma, and neoplastic diseases other than esophageal cancer (duodenal cancer, adenoma, etc.)
d) Presence or absence of eradication treatment, degree of mucosal atrophy (Kimura-Takemoto classification), and time to onset of gastric cancer and gastric adenoma
e) Presence or absence of eradication treatment, evaluation according to the Kyoto Gastritis Classification, and time to onset of gastric cancer and gastric adenoma
f) Analysis of factors related to the prognosis of gastric cancer and gastric adenoma with or without eradication treatment
g) Verification of the effect of Helicobacter pylori eradication treatment on the onset of gastric cancer and gastric adenoma
h) Changes over time in the incidence rate of gastric cancer and gastric adenoma after eradication
i) Annual trends in autoimmune gastritis and eosinophilic gastroenteritis
j) Analysis of the relationship between autoimmune gastritis/eosinophilic gastroenteritis and the onset of gastric cancer/gastric adenoma
k) Time to onset of esophageal cancer/duodenal epithelial tumors in groups with and without eradication therapy
l) Analysis of factors related to the prognosis of esophageal cancer/duodenal epithelial tumors in groups with and without eradication therapy
m) Verification of the effectiveness of eradication therapy in the onset of esophageal cancer/duodenal epithelial tumors
Observational
20 | years-old | <= |
100 | years-old | > |
Male and Female
1) All persons who underwent at least one upper endoscopy or gastric X-ray between January 1, 2001 and December 31, 2023 at the screening medical institution.
2) Those who are 20 years of age or older at the time of the upper endoscopy or gastric X-ray (if the person undergoes the examination when he/she is under 20 years of age, he/she is not included, but if he/she undergoes the examination after 20 years of age, he/she is included in all cases).
Participating Facilities
1) Japan Community Health Care Organization Shiga Hospital
2) Japanese Red Cross Society Kyoto Daini Hospital
3) Tsukuba Preventive Medicine Research Center
4) JA Kagoshima Koseiren Hospital
5) Yotsuya Medical Cube
6) Yamagata City Medical Association Medical Checkup Center
7) Medical Check-up Center Wellness
8) Tokushima Health Screening Centers
9) Nara Health Promotion Center
10) Uda City Hospital
11) Center for Digestive Endoscopy, Ibarakiken Medical Center
12) Kameda Makuhari Clinic
13) Kameda Medical Center
14) Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
15) KKR Takamatsu Hospital
16) Center for Epidemiology and Preventive Medicine The University of Tokyo Hospital
Persons who did not receive permission to use data due to opt-out
1800000
1st name | Nobutake |
Middle name | |
Last name | Yamamichi |
The University of Tokyo Hospital
Center for Epidemiology and Preventive Medicine
1138655
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
03-3815-5411
nyamamic-tky@umin.ac.jp
1st name | Yusuke |
Middle name | |
Last name | Mitsui |
The University of Tokyo Hospital
Center for Epidemiology and Preventive Medicine
1138655
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
03-5800-9033
yusuke.mp1016@gmail.com
The University of Tokyo Hospital
Nobutake Yamamichi
The University of Tokyo Hospital
Other
The University of Tokyo Hospital
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
03-5800-9033
yusuke.mp1016@gmail.com
NO
2025 | Year | 07 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2024 | Year | 08 | Month | 29 | Day |
2024 | Year | 09 | Month | 17 | Day |
2024 | Year | 09 | Month | 17 | Day |
2024 | Year | 12 | Month | 31 | Day |
At each medical institution, an opt-out notice will be displayed for 6 months in accordance with the institution's guidelines. After the 6-month opt-out period, data (including basic information, test results, Helicobacter pylori-related information, events, atrophy diagnoses, gastritis diagnoses, and other clinical information) will be collected for individuals who meet the inclusion criteria and do not meet the exclusion criteria using an Excel sheet.
An Excel sheet prepared by the data center will be distributed to each facility. Each facility will anonymize the participant IDs, assign new research IDs, and input the data into the Excel sheet. The data will then be subjected to dual encryption (password protection for file access and password protection for compression) before being sent to the data center of the primary institution. The data center will compile the data collected from all participating medical institutions. The correspondence table between participant IDs and research IDs will be securely stored in a safe at each medical institution. Data and correspondence tables must be stored in separate locations.
The method of converting participant IDs to research IDs will follow the "Guidelines on the Protection of Personal Information" to generate anonymized IDs. These anonymized IDs will then be combined with a 3-letter alphabetic code specific to each medical institution (details provided later) to create research IDs. After integrating all data from participating medical institutions, the primary institution will perform data analysis.
2025 | Year | 07 | Month | 01 | Day |
2025 | Year | 07 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064380