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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031873
Receipt No. R000036313
Scientific Title The establishment of diagnostic criteria for Birt-Hogg-Dube (BHD) syndrome and equalization of ability of diagnosing and managing BHD in Japan (multicenter collaborative study)
Date of disclosure of the study information 2018/04/01
Last modified on 2019/05/07

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Basic information
Public title The establishment of diagnostic criteria for Birt-Hogg-Dube (BHD) syndrome and equalization of ability of diagnosing and managing BHD in Japan (multicenter collaborative study)
Acronym The establishment of diagnostic criteria for Birt-Hogg-Dube (BHD) syndrome and equalization of ability of diagnosing and managing BHD in Japan (multicenter collaborative study)
Scientific Title The establishment of diagnostic criteria for Birt-Hogg-Dube (BHD) syndrome and equalization of ability of diagnosing and managing BHD in Japan (multicenter collaborative study)
Scientific Title:Acronym The establishment of diagnostic criteria for Birt-Hogg-Dube (BHD) syndrome and equalization of ability of diagnosing and managing BHD in Japan (multicenter collaborative study)
Region
Japan

Condition
Condition Birt-Hogg-Dube syndrome
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 We perform skin biopsy and FLCN gene test for cases suspected of BHD syndrome.
Our research is aimed at establishing diagnostic criteria for BHD syndrome and accumulation of clinical experience.
Basic objectives2 Others
Basic objectives -Others establishing diagnostic criteria for BHD syndrome and accumulation of clinical experience.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequency of skin lesions, pathological findings of skin lesion, type of FLCN gene mutation, characteristics of clinical phenotypes
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 Diagnosis
Type of intervention
Gene
Interventions/Control_1 Analysis of germline FLCN mutation and Dermatological evaluation of face and upper chest (biopsy of skin papule may be performed if indicated)
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients with spontaneous pneumothroax whose computed tomography of the chest showed multiple pulmonary cysts that have features typical for that of BHD syndrome are the candicate for this study. Patients can participatein the study if they give the written informed consent to FLCN genetic testing and dermatoloigc evaluation after the explanation of the study.
Key exclusion criteria Patients with spontaneous pneumothroax whose computed tomography of the chest showed multiple pulmonary cysts, but those not having typical features of BHD syndrome, will be excluded.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kuniaki Seyama
Organization Juntendo University Faculty of Medicine and Graduate School of Medicine
Division name Respiratory Medicine
Zip code
Address 3-1-3 Hongo Bunkyo-ku Tokyo
TEL 03-5802-1063
Email kseyama@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kuniaki Seyama
Organization Juntendo University Faculty of Medicine and Graduate School of Medicine
Division name Respiratory Medicine
Zip code
Address 3-1-3 Hongo Bunkyo-ku Tokyo
TEL 03-5802-1063
Homepage URL
Email kseyama@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization Juntendo University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor The Japan Society for Pneumothorax and Cystic Lung Disease
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 04 Month 01 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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 08 Day
Date of IRB
2018 Year 01 Month 23 Day
Anticipated trial start date
2018 Year 01 Month 23 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 23 Day
Last modified on
2019 Year 05 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036313

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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