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

Email

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


Email

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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name