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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029320
Receipt No. R000033497
Scientific Title Immune function analysis after sirolimus treatment for pediatric patients with intractable vascular anomalies
Date of disclosure of the study information 2017/09/29
Last modified on 2017/09/27

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Basic information
Public title Immune function analysis after sirolimus treatment for pediatric patients with intractable vascular anomalies
Acronym Immune function analysis after sirolimus treatment for pediatric patients with intractable vascular anomalies
Scientific Title Immune function analysis after sirolimus treatment for pediatric patients with intractable vascular anomalies
Scientific Title:Acronym Immune function analysis after sirolimus treatment for pediatric patients with intractable vascular anomalies
Region
Japan

Condition
Condition Intractable vascular anomalies
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine Pneumology
Hematology and clinical oncology Neurology Surgery in general
Hepato-biliary-pancreatic surgery Vascular surgery Chest surgery
Pediatrics Dermatology Oto-rhino-laryngology
Orthopedics Radiology Oral surgery
Neurosurgery Plastic surgery Aesthetic surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate immune function analysis after sirolimus treatment for the Japanese pediatric patients
Basic objectives2 Others
Basic objectives -Others To research the association between the sirolimus treatment and infection frequency
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Immune function analysis after sirolimus treatment for the Japanese pediatric patients
Key secondary outcomes The association between the sirolimus treatment and infection frequency

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 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michio Ozeki
Organization Gifu University Hospital
Division name The department of Pediatrics
Zip code
Address 1-1 Yanagito, Gifu-shi, Gifu-ken
TEL 058-230-6000
Email michioo@gifu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michio Ozeki
Organization Gifu University Hospital
Division name The department of Pediatrics
Zip code
Address 1-1 Yanagito, Gifu-shi, Gifu-ken
TEL 058-230-6000
Homepage URL
Email michioo@gifu-u.ac.jp

Sponsor
Institute Gifu University
Institute
Department

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
Address
Tel
Email

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 29 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
2017 Year 08 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information For more information, please contact the Principal Investigator.

Management information
Registered date
2017 Year 09 Month 27 Day
Last modified on
2017 Year 09 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033497

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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