UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029174 |
|---|---|
| Receipt number | R000033352 |
| Scientific Title | The national registry for intractable vascular anomalies |
| Date of disclosure of the study information | 2017/09/17 |
| Last modified on | 2024/12/25 14:18:51 |
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Basic information
Public title
The national registry for intractable vascular anomalies
Acronym
The national registry for intractable vascular anomalies
Scientific Title
The national registry for intractable vascular anomalies
Scientific Title:Acronym
The national registry for intractable vascular anomalies
Region
| Japan |
Condition
Condition
Intractable vascular anomalies
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
| Neurology | Surgery in general | Vascular surgery |
| Chest surgery | Pediatrics | Dermatology |
| Oto-rhino-laryngology | Orthopedics | Radiology |
| Oral surgery | Neurosurgery | Aesthetic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To construct the national registry system of intractable vascular anomalies (vascular tumors with kasabach-merritt phenomenon, lymphatic anomalies, and so on)
Basic objectives2
Others
Basic objectives -Others
To correct the clinical data for development of pathogenesis and treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of intractable vasacular anomalies in Japan
Key secondary outcomes
1. The differences of clinical symptoms and prognosis of each vascular anomalies
2. The comparison of clinical parameters (respiratory function, pleural effusion, coagulation data, pain scales, bleeding scales, severity)
3. The efficacy of each treatments
4. Clinical validity of severity scores
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
Intractable vascular anomalies who visited to the hospital from 2007 to 2022
Key exclusion criteria
Patients who have had an offer of non-participation in research
Patients who have not left enough clinical record information
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Michio |
| Middle name | |
| Last name | Ozeki |
Organization
Gifu University Hospital
Division name
The department of Pediatrics
Zip code
5011192
Address
1-1 Yanagito, Gifu-shi, Gifu-ken
TEL
058-230-6000
michioo@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Michio |
| Middle name | |
| Last name | Ozeki |
Organization
Gifu University Hospital
Division name
The department of Pediatrics
Zip code
5011192
Address
1-1 Yanagito, Gifu-shi, Gifu-ken
TEL
058-230-6000
Homepage URL
michioo@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu University
Address
1-1 Yanagito, Gifu-shi, Gifu-ken
Tel
058-230-6059
rinri@gifu-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
| 2017 | Year | 09 | Month | 17 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 25 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 25 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 25 | Day |
Other
Other related information
Lymphatic disease information station(http://lymphangioma.net/index.html)
Management information
Registered date
| 2017 | Year | 09 | Month | 17 | Day |
Last modified on
| 2024 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033352
