UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053576 |
|---|---|
| Receipt number | R000061137 |
| Scientific Title | Nationwide survey on visceral AVMs associated with Osler's disease (Hereditary Hemorrhagic Telangiectasia) (a multi-center, retrospective study) |
| Date of disclosure of the study information | 2024/02/14 |
| Last modified on | 2025/02/08 09:06:04 |
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Basic information
Public title
Nationwide survey on visceral AVMs associated with Osler's disease (Hereditary Hemorrhagic Telangiectasia)
(a multi-center, retrospective study)
Acronym
Nationwide survey on visceral AVMs associated with Osler's disease (HHT)
Scientific Title
Nationwide survey on visceral AVMs associated with Osler's disease (Hereditary Hemorrhagic Telangiectasia)
(a multi-center, retrospective study)
Scientific Title:Acronym
Nationwide survey on visceral AVMs associated with Osler's disease (HHT)
Region
| Japan |
Condition
Condition
Osler's disease (Hereditary Hemorrhagic Telangiectasia)
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to investigate the presence of visceral AVMs in HHT patients, their symptoms and treatments, and the correlation with the results of genetic testing in Japan.
Basic objectives2
Others
Basic objectives -Others
In this study, the frequency of AVM/AVF in each organ associated with HHT and the relationship with the results of genetic testing will be collected jointly at HHT treatment centers in Japan, which will provide meaningful findings that can be fed back to clinical practice, enabling physicians to offer appropriate testing and treatment and provide very useful information for systemic disease management in HHT patients in Japan.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The prevalence of visceral AVMs, symptomatic prevalence, and the proportion of patients treated for them will be analyzed to assess the frequency of HHT-associated visceral AVMs in Japan. In addition, for those for which genetic test results are available, we will analyze the prevalence of HHT1 (ENG gene mutation) and HHT2 (ACVRL1 gene mutation) in terms of the prevalence of visceral AVMs, symptomatic prevalence, and the proportion of patients treated for them. The differences in visceral AVMs by HHT subtype will also be evaluated.
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 who visited HHT clinics participating in this study between January 1, 2022 and December 31, 2022, and met either of the following two conditions
(a) Patients met 3 or 4 of the Curacao criteria for clinical diagnosis of HHT.
(b) The HHT gene test showed pathogenic mutations in the ENG gene, ACVRL1 gene, or SMAD4 gene.
Key exclusion criteria
1 Patients with insufficient medical information
2 Patients deemed inappropriate by the principal investigator or subinvestigator to conduct this study
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Takenori |
| Middle name | |
| Last name | Akiyama |
Organization
School of Medicine, Keio University
Division name
Department of Neurosurgery
Zip code
160-8582
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
TEL
+81-3-3353-1211
akiyamanor@gmail.com
Public contact
Name of contact person
| 1st name | Takeo |
| Middle name | |
| Last name | Nishida |
Organization
Hyogo Prefectural Nishinomiya Hospital
Division name
Department of Neurosurgery
Zip code
662-0918
Address
Rokutanji-cho 13-9, Nishinomiya, Hyogo
TEL
+81-798-34-5151
Homepage URL
takeonsd@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Keio University, ethics committee
Address
Shinanomachi 35, Shinjuku-ku, Tokyo
Tel
+81-3-3353-1211
https://www.ctr.med.keio.ac.jp/forms/
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
| 2024 | Year | 02 | Month | 14 | 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
722
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to investigate the presence of visceral AVMs in HHT patients, their symptoms and treatments, and the correlation with the results of genetic testing in Japan.
Management information
Registered date
| 2024 | Year | 02 | Month | 08 | Day |
Last modified on
| 2025 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061137
