UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019506 |
|---|---|
| Receipt number | R000022549 |
| Scientific Title | Molecular biological study of atrophic gastritis and gastric cancer by culturing the human gastric tissue |
| Date of disclosure of the study information | 2015/10/27 |
| Last modified on | 2025/05/06 07:47:43 |
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Basic information
Public title
Molecular biological study of atrophic gastritis and gastric cancer by culturing the human gastric tissue
Acronym
Molecular biological study of atrophic gastritis and gastric cancer by culturing the human gastric tissue
Scientific Title
Molecular biological study of atrophic gastritis and gastric cancer by culturing the human gastric tissue
Scientific Title:Acronym
Molecular biological study of atrophic gastritis and gastric cancer by culturing the human gastric tissue
Region
| Japan |
Condition
Condition
atrophic gastritis, gastric cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Establishment of human gastric epithelial organoid.
Basic objectives2
Others
Basic objectives -Others
Elucidation of molecular mechanism involved in atrophic gastritis and gastric cancer by using the experiment systems with human gastric organoids.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Survival rate of organoids at 2 and 4 weeks after generation.
Key secondary outcomes
Speed of growth, Form of organoids, State of differentiation. Expression of gene involved in the cells constructing the organoids.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Taking tissue samples from the stomach extirpated by operation.
Interventions/Control_2
Taking mucous membrane samples from the stomach by esophagogastroduodenoscopy.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age over 20
No past surgical history of stomach
Patients who will have gastrectomy to treat disease or have necessity of esophagogastroduodenoscopy in the medical service.
Informed consent is obtained by sentence
Key exclusion criteria
Patients who are taking two or more oral anti-platelet agents.
Patients who are taking anticoagulant.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hamada Fumihiko |
Organization
Faculty of Medicine, Oita University
Division name
Department of Human Anatomy
Zip code
Address
1-1, Idaigaoka, Hasamamachi, Yufu City, Oita Prefecture, Japan
TEL
097-586-5620
hamadaf1@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinari Kawahara |
Organization
Faculty of Medicine, Oita University
Division name
Department of Gastroenterology
Zip code
Address
1-1, Idaigaoka, Hasamamachi, Yufu City, Oita Prefecture, Japan
TEL
097-549-4411
Homepage URL
kawaharay@oita-u.ac.jp
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
Funding Source
Organization
Oita University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 10 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 26 | Day |
Last modified on
| 2025 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022549
