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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042002
Receipt No. 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 2020/10/03

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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
Email d-sakahara@med.osakacity-hp.or.jp

Public contact
Name of contact person
1st name Keisuke
Middle name
Last name Imai
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
Email k-imai@med.osakacity-hp.or.jp

Sponsor
Institute Osaka City General hospital, &Plastic & Plastic
&Reconstrucitve surgery
Institute
Department

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
Email 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
2020 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047695

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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