UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052317 |
|---|---|
| Receipt number | R000059726 |
| Scientific Title | Establishment of Peripheral Blood-Derived Induced Pluripotent Stem Cells (iPS Cells) in Patients with Gastric Polyposis |
| Date of disclosure of the study information | 2023/09/27 |
| Last modified on | 2023/09/27 09:00:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Establishment of Peripheral Blood-Derived Induced Pluripotent Stem Cells (iPS Cells) in Patients with Gastric Polyposis
Acronym
Establishment of Peripheral Blood-Derived Induced Pluripotent Stem Cells (iPS Cells) in Patients with Gastric Polyposis
Scientific Title
Establishment of Peripheral Blood-Derived Induced Pluripotent Stem Cells (iPS Cells) in Patients with Gastric Polyposis
Scientific Title:Acronym
Establishment of Peripheral Blood-Derived Induced Pluripotent Stem Cells (iPS Cells) in Patients with Gastric Polyposis
Region
| Japan |
Condition
Condition
Gastric polyposis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To elucidate the mechanism of gastric polyp formation in patients with gastric polyposis, we establish induced pluripotent stem cells (iPS cells) from peripheral blood of both gastric polyposis patients and patients without gastric polyposis (control group). Subsequently, we generate gastric organoids from iPS cells established from each patient and analyze the morphology of these organoids
Basic objectives2
Others
Basic objectives -Others
To elucidate the mechanism of gastric polyp formation in patients with gastric polyposis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We establish induced pluripotent stem cells (iPS cells) from peripheral blood of both gastric polyposis patients and patients without gastric polyposis (control group). Subsequently, we generate gastric organoids from iPS cells established from each patient and analyze the morphology of these organoids.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with and without gastric polyposis
Key exclusion criteria
None
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Iwamuro |
Organization
Okayama University Hospital
Division name
Department of Gastroeneterology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357218
iwamuromasaya@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Iwamuro |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357218
Homepage URL
iwamuromasaya@yahoo.co.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Masaya Iwamuro
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University IRB
Address
2-5-1 Shikata-cho, Kita-ku
Tel
086-235-6938
MAE6605@adm.okayama-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
| 2023 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
As a primary outcome, we establish induced pluripotent stem cells (iPS cells) from the peripheral blood of both gastric polyposis patients and patients without gastric polyposis, generate gastric organoids, and compare their morphology (three-dimensional structure).
Management information
Registered date
| 2023 | Year | 09 | Month | 27 | Day |
Last modified on
| 2023 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059726
