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Recruitment status Completed
Unique ID issued by UMIN UMIN000008745
Receipt No. R000010263
Scientific Title Evaluation of dysplastic bone transplantation in patient with McCune-Albright syndrome.
Date of disclosure of the study information 2012/08/22
Last modified on 2014/03/14

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Basic information
Public title Evaluation of dysplastic bone
transplantation in patient with McCune-Albright syndrome.
Acronym Evaluation of dysplastic bone
transplantation in patient with McCune-Albright syndrome.
Scientific Title Evaluation of dysplastic bone
transplantation in patient with McCune-Albright syndrome.
Scientific Title:Acronym Evaluation of dysplastic bone
transplantation in patient with McCune-Albright syndrome.
Region
Japan

Condition
Condition McCune-Albright syndrome
mandibular defect
Classification by specialty
Oral surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate of dysplastic bone as a graft material.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Successful grafting of dysplastic bone
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Dysplastic bone grafting is performed in a patient with McCune-Albright syndrome.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient with McCune-Albright syndrome who should undergo removal of dysplastic bone and grafting of bone.
Key exclusion criteria Patient with McCune-Albright syndrome who have healthy donor site of bone or do not need to undergo removal of dysplastic bone.
Target sample size 1

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Nariai
Organization Shimane University Faculty of Medicine
Division name Dept. Oral and Maxillofacial Surgery
Zip code
Address 89-1 Enya-Cyo, Izumo City, Shimane, Japan
TEL 0853-20-2301
Email omfs16@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoishiki Nariai
Organization Shimane University Faculty of Medicine
Division name Dept. Oral and Maxillofacial Surgery
Zip code
Address 89-1 Enya-Cyo, Izumo City, Shimane, Japan
TEL 0853-20-2301
Homepage URL
Email omfs16@med.shimane-u.ac.jp

Sponsor
Institute Dept. Oral and Maxillofacial Surgery, Shimane University Faculty of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization None
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
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

Other administrative information
Date of disclosure of the study information
2012 Year 08 Month 22 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
2012 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 01 Day
Last follow-up date
2013 Year 10 Month 21 Day
Date of closure to data entry
2013 Year 10 Month 29 Day
Date trial data considered complete
2013 Year 10 Month 29 Day
Date analysis concluded
2014 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 08 Month 21 Day
Last modified on
2014 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010263


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