UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007248 |
|---|---|
| Receipt number | R000008543 |
| Scientific Title | A study of collecting comprehensive samples for rare intractable skin diseases in human being |
| Date of disclosure of the study information | 2012/02/08 |
| Last modified on | 2019/08/15 14:25:00 |
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Basic information
Public title
A study of collecting comprehensive samples for rare intractable skin diseases in human being
Acronym
A study of collecting comprehensive samples
Scientific Title
A study of collecting comprehensive samples for rare intractable skin diseases in human being
Scientific Title:Acronym
A study of collecting comprehensive samples
Region
| Japan |
Condition
Condition
pemphigus, pustular psoriasis, epidermolysis bullosa hereditaria, congenital ichthyosiform erythroderma, neurofibromatosis(type1,2), xeroderma pigmentosum, tuberous sclerosis
Classification by specialty
| Dermatology | Adult | Child |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Seven diseases (pemphigus, pustular psoriasis, epidermolysis bullosa hereditaria, congenital ichthyosiform erythroderma, neurofibromatosis (type 1 and 2), xeroderma pigmentosum, and tuberous sclerosis) be studied, and a permanent system will be developed to manage biological samples of rare and intractable skin diseases under strict quality control. Not only biological samples of rare and intractable skin diseases will be stored to provide storage of samples for genetic analyses, but the registry will also contain patients' clinical information. In order to achieve its purpose, a dermatologist familiar with these diseases is needed to operate the consolidated clinical information and biological sample collection. While seeking close cooperation with a study group performing research on neurocutaneous syndromes and a team doing research on rare intractable skin diseases, which is the parent body, joint research on the diagnosis and treatment of refractory rare skin diseases in Japan will be facilitated by improving the management of a valid collection of biological samples. Biological samples (gene, serum, skin tissue) will be collected from patients with target diseases, and an appropriate management structure will be developed that will contribute to the administration of health care in Japan. This collection system of biological samples will provide a permanent basis, in order to develop innovative diagnostic methods and therapies for intractable skin diseases.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This study is intended to produce a framework for centralized projects involving a Research Resources Bank for intractable diseases for the long-term that will be effectively used for research studies on incurable skin diseases using samples donated by patients.
Key secondary outcomes
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria for the patients are
1) Patient (male and female) under the age of 75 years at the time of obtaining informed consent
2) Patients who meet any of the following three diagnostic criteria
(1) Diagnostic criteria proposed by a research group of the intractable rare skin diseases
(2) Diagnostic criteria proposed by a research group of the neurocutaneous syndrome
(3) Diagnostic guidelines proposed by the Japanese Dermatological Association
3) Patient receives an adequate explanation prior to participation in this study and voluntarily gives informed consent: if the patient age is under the age of 20 years, informed consent is obtained from the patient's parents or a legal representative
4) Hospital outpatient and inpatient
Key exclusion criteria
Patients who fall under the following are not included in this study:
1) 75 years of age or more at diagnosis
2) Patients who do not have health insurance
3) HBs antigen-positive
4) Patients with unstable angina
5) Patients with severe liver damage (AST(GOT) or ALT(GPT) > 100 IU/L)
6) Patients with severe renal damage (serum creatinine > 2.0 mg/dL or BUN > 25 mg/dL)
7) Patients who are pregnant or have a possibility of pregnancy
8) Lactating women
9) Others deemed inappropriate as subjects for the research by the doctor conducting the research
10) Neurofibromatosis (1) patients with only cafe au lait spots
Target sample size
584
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Shimomura |
Organization
Yamaguchi university graduate school of medicine, dermatology
Division name
dermatology
Zip code
755-8505
Address
1-1-1,MinamiKogushi,Ube City,Yamaguchi Prefecture,Japan 755-8505
TEL
0836-22-2271
yshimo@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Yutaka Shimomura |
Organization
Yamaguchi university graduate school of medicine, department of dermatology
Division name
dermatology
Zip code
755-8505
Address
1-1-1,MinamiKogushi,Ube City,Yamaguchi Prefecture,Japan 755-8505
TEL
0836-22-2271
Homepage URL
yshimo@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi university graduate school of medicine, department of dermatology
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi university graduate school of medicine, department of dermatology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamaguchi University Hospital
Address
1-1-1,MinamiKogushi,Ube City,Yamaguchi Prefecture,Japan
Tel
0836-22-2428
me223@yamaguchi-u.ac.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
| 2012 | Year | 02 | Month | 08 | 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
33
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
| 2010 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2011 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
We have finished the study on March 31, 2019.
Management information
Registered date
| 2012 | Year | 02 | Month | 08 | Day |
Last modified on
| 2019 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008543
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/02/12 | final-下村-加筆-【5版】H23-33-4 実施計画書.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2018/02/12 | 仕様書.jpg |
| Research case data | |
|---|---|
| Registered date | File name |
| 2018/02/12 | 症例.jpg |
