UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008745 |
|---|---|
| Receipt number | 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 16:59:12 |
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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
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
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
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
omfs16@med.shimane-u.ac.jp
Sponsor or person
Institute
Dept. Oral and Maxillofacial Surgery, Shimane University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010263
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
