UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056927 |
|---|---|
| Receipt number | R000064892 |
| Scientific Title | Prospective study for incidence of gastric cancer with the expression of some genes of gastric specimens |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2025/02/04 11:32:11 |
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Basic information
Public title
A study for the prediction of gastric cancer incidence
Acronym
A study for the prediction of gastric cancer incidence
Scientific Title
Prospective study for incidence of gastric cancer with the expression of some genes of gastric specimens
Scientific Title:Acronym
Prospective study for incidence of gastric cancer with the expression of some genes of gastric specimens
Region
| Japan |
Condition
Condition
Atrophic gastritis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether the positive rate of gene(s) expression is improved by this technology compared to previous technologies.
Basic objectives2
Others
Basic objectives -Others
To evaluate the association between specific gene expression in cases of atrophic gastritis and the development of future gastric cancer.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gene expression rates should be improved over previous technologies.
Observe whether gastric cancer develops within the fifth year since the gene expression testing.
Key secondary outcomes
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Informed consent to participate in the study (IC) will be obtained at Kitasato University Hospital and KMC for patients aged 18 years or older, in good general condition, considered eligible for endoscopy up to 5 years from the date of approval by the head of the research institute to 31 March 2028, who are judged to have atrophic changes and suspected atrophy at the time of examination. Patients who have undergone upper gastrointestinal endoscopy and have endoscopically detected atrophic changes will be selected. In addition, as negative control cases, ICs will be obtained from patients who are assumed not to have atrophic changes on examination prior to endoscopy and who do not meet the exclusion criteria, and upper gastrointestinal endoscopy will be performed and patients without endoscopic evidence of atrophic changes will be selected.
Key exclusion criteria
The following patients should be excluded.
(i) Patients judged by the endoscopist to be at high risk of an accidental biopsy based on patient background and other factors.
(ii) Cases in which the research use was refused.
(iii) Patients with gastric cancer or a history of gastric cancer.
(iv) Cases with a history of surgical resection of the upper gastrointestinal tract.
(v) Cases with severe co-morbidities and prognosis of less than 5 years.
(vi) Cases in which biopsy is deemed impossible due to antithrombotic medication.
(vii) Pregnant or lactating women.
(viii) Patients with abnormal blood coagulation disorders.
(ix) Cases in which the principal investigator or co-principal investigator considers that participation in the study is inappropriate.
Target sample size
330
Research contact person
Name of lead principal investigator
| 1st name | Chika |
| Middle name | |
| Last name | Kusano |
Organization
Kitasato University
Division name
Department of Gastroenterology
Zip code
2520374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8111
c-kusano@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Gen |
| Middle name | |
| Last name | Kitahara |
Organization
Kitasato University
Division name
Department of Gastroenterology
Zip code
2520374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8111
Homepage URL
genkit@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Kitasato University School of Medicine and Hospital Ethics Committee
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel
042-778-8111
rinri@med.kitasato-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
| 2025 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2033 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observe for the development of gastric cancer 5 years after biopsy.
Management information
Registered date
| 2025 | Year | 02 | Month | 04 | Day |
Last modified on
| 2025 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064892
