UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059021 |
|---|---|
| Receipt number | R000067500 |
| Scientific Title | Identification of genetic variants associated with Chronic idiopathic intestinal pseudo-obstruction and development of blood screening test |
| Date of disclosure of the study information | 2025/09/06 |
| Last modified on | 2025/09/06 20:43:49 |
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Basic information
Public title
Identification of genetic variants associated with chronic idiopathic intestinal pseudo-obstruction and development of blood screening test
Acronym
Genetic analysis and screening of CIIPO
Scientific Title
Identification of genetic variants associated with Chronic idiopathic intestinal pseudo-obstruction and development of blood screening test
Scientific Title:Acronym
Genetic analysis and screening of CIIPO
Region
| Japan |
Condition
Condition
chronic idiopathic intestinal pseudo-obstruction
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Patients with chronic idiopathic intestinal pseudo-obstruction may develop at a young age and familial onset, therefore, genetic factors are strongly suspected to be associated with its pathogenesis. In addition, a delay in diagnosis from onset to diagnosis has been noted, and blood biomarkers will be explored.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Identification of pathogenic genes and blood biomarkers
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with established or suspected chronic idiopathic intestinal pseudo-obstruction
Key exclusion criteria
Patients with chronic secondary intestinal pseudo-obstruction
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Ohmiya |
Organization
Fujita Health University School of Medicine
Division name
Department of Advanced Endoscopy
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
TEL
0562939240
nohmiya@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Ohmiya |
Organization
Fujita Health University Hospital
Division name
Department of Advanced Endoscopy
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
TEL
0562939240
Homepage URL
nohmiya@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
Naoki Ohmiya
Funding Source
Organization
Fujita Health 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
The Institutional Review Board of Fujita University School of Medicine
Address
1-98 Dengakugakubo, Kutsukake-cho
Tel
0562-93-2860
research@fujita-hu.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
愛知県
Institutions
Institutions
藤田医科大学病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 06 | 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
50
Results
We are now entering patients and analyzing.
Results date posted
| 2025 | Year | 09 | Month | 06 | Day |
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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 12 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 09 | Month | 06 | Day |
Last modified on
| 2025 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067500
