UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042002 |
|---|---|
| Receipt number | R000047695 |
| Scientific Title | Long term follow up clinical study of cultured epithelial autografts for patients with giant congenital melanocytic nevus. |
| Date of disclosure of the study information | 2020/10/05 |
| Last modified on | 2022/09/27 09:21:39 |
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Basic information
Public title
Long term follow up clinical study of cultured epithelial autografts for patients with giant congenital melanocytic nevus.
Acronym
Clinical study of cultured epithelial autografts for patients with giant congenital melanocytic nevus.
Scientific Title
Long term follow up clinical study of cultured epithelial autografts for patients with giant congenital melanocytic nevus.
Scientific Title:Acronym
Clinical study of cultured epithelial autografts for patients with giant congenital melanocytic nevus.
Region
| Japan |
Condition
Condition
Giant congenital melanocytic nevi (GCMN)
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of surgical procedures
Basic objectives2
Others
Basic objectives -Others
Evaluation of postoperative scars and cosmetic results, and complications
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Each state of the grafted site after operation(erosion,ulcer, contracture,infection, cosmetic results)
Key secondary outcomes
Incidence rates of neoplastic skin lesions,allergy,infection
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
1)patients with GCMN to whom cultured epithelial autografts transplanted
2)patients with complete medical records who have clinical photo.
Key exclusion criteria
1)patients didn't have given written informed consent.
2)Patients who are judged to be unsuitable as a subject by the research responsibility doctors
3)Clinical photographs and medical records not fully described
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Sakahara |
Organization
Osaka City General Hospital
Division name
Plastic & Reconstructive Surgery
Zip code
5340021
Address
2-13-22,Miyakojimahondori,miyakojima-ku,Osaka
TEL
0669291221
d-sakahara@med.osakacity-hp.or.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Sakahara |
Organization
Osaka City General Hospital
Division name
Plastic & Reconstructive Surgery
Zip code
5340021
Address
2-13-22,Miyakojimahondori,miyakojima-ku,Osaka
TEL
0669291221
Homepage URL
d-sakahara@med.osakacity-hp.or.jp
Sponsor or person
Institute
Osaka City General hospital, &Plastic & Plastic
&Reconstrucitve surgery
Institute
Department
Personal name
Funding Source
Organization
Osaka City Environment and Public Health Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Committee,Osaka City General Hospital
Address
Miyakojima center Bil. 2F, 5-12-21,Nakanocho,Miyakojima,Osaka
Tel
0669293269
xc0017@osakacity-hp.or.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
| 2020 | Year | 10 | Month | 05 | 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
| 2019 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
If meaningful results are obtained during this study, only the results may be reported at medical conferences and/or medical journals during the course of the study.
Management information
Registered date
| 2020 | Year | 10 | Month | 04 | Day |
Last modified on
| 2022 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047695
