UMIN-ICDS Clinical Trial

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

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Basic information

Public title

A multicenter retrospective study on gastric cancer screening considering H. pylori infection

Acronym

A multicenter retrospective study on gastric cancer screening considering H. pylori infection

Scientific Title

A multicenter retrospective study on gastric cancer screening considering H. pylori infection

Scientific Title:Acronym

A multicenter retrospective study on gastric cancer screening considering H. pylori infection

Region

Japan


Condition

Condition

gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

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)

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Association between the preventive effect of H. pylori eradication treatment and the development of gastric cancer

Key secondary outcomes

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


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

20 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

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

Key exclusion criteria

Persons who did not receive permission to use data due to opt-out

Target sample size

1800000


Research contact person

Name of lead principal investigator

1st name Nobutake
Middle name
Last name Yamamichi

Organization

The University of Tokyo Hospital

Division name

Center for Epidemiology and Preventive Medicine

Zip code

1138655

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-3815-5411

Email

nyamamic-tky@umin.ac.jp


Public contact

Name of contact person

1st name Yusuke
Middle name
Last name Mitsui

Organization

The University of Tokyo Hospital

Division name

Center for Epidemiology and Preventive Medicine

Zip code

1138655

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-5800-9033

Homepage URL


Email

yusuke.mp1016@gmail.com


Sponsor or person

Institute

The University of Tokyo Hospital

Institute

Department

Personal name

Nobutake Yamamichi


Funding Source

Organization

The University of Tokyo Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

The University of Tokyo Hospital

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan

Tel

03-5800-9033

Email

yusuke.mp1016@gmail.com


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

2025 Year 07 Month 01 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

2024 Year 08 Month 29 Day

Date of IRB

2024 Year 09 Month 17 Day

Anticipated trial start date

2024 Year 09 Month 17 Day

Last follow-up date

2024 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

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.


Management information

Registered date

2025 Year 07 Month 01 Day

Last modified on

2025 Year 07 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064380