UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029173 |
|---|---|
| Receipt number | R000033351 |
| Scientific Title | The study of biomarkers for intractable vascular anomalies and associated with pharmacological action of sirolimus |
| Date of disclosure of the study information | 2017/09/17 |
| Last modified on | 2024/03/23 09:13:44 |
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Basic information
Public title
The study of biomarkers for intractable vascular anomalies and associated with pharmacological action of sirolimus
Acronym
The study of biomarkers for intractable vascular anomalies
Scientific Title
The study of biomarkers for intractable vascular anomalies and associated with pharmacological action of sirolimus
Scientific Title:Acronym
The study of biomarkers for intractable vascular anomalies
Region
| Japan |
Condition
Condition
Vascular anomalies
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
| Surgery in general | Vascular surgery | Chest surgery |
| Pediatrics | Dermatology | Oto-rhino-laryngology |
| Orthopedics | Oral surgery | Neurosurgery |
| Cardiovascular surgery | Plastic surgery | Aesthetic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To search the disease-specific biomarkers for vascular anomalies
Basic objectives2
Others
Basic objectives -Others
To investigate the change and relativity of the efficacy and safety of the sirolimus (mTOR inhibitor) treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relativity between the efficacy and safety of the sirolimus treatment and cytokine
Key secondary outcomes
The difference of disease-specific biomarkers for vascular anomalies.
The change of cytokine after sirolimus treatment.
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
Key exclusion criteria
1. Patients with a history of hypersensitivity to ingredients of this drug
2. Patients with serious liver and renal disorders
3. Patients with symptoms that affect cytokine value of such obvious infection at the time of specimen collection
4. Patients must also avoid strong inducers of CYP3A4
5. Past usage of mTOR inhibitors or other molecular target drugs relating mTOR pathway
6. Patient who is judged inappropriate to participate in this study by the investigators
Target sample size
50
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
503-0015
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
503-0015
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
Tel
058-230-6000
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
(国立成育医療研究センター（東京都）、慶應義塾大学病院（東京都）、京都府立医科大学附属病院（京都）、九州大学病院（福岡県）、浜松医科大学（静岡県）
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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
For more information, please contact the Principal Investigator.
Management information
Registered date
| 2017 | Year | 09 | Month | 17 | Day |
Last modified on
| 2024 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033351
