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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010835
Receipt No. R000012646
Scientific Title A Study on the Genetics of Autoimmune Alveolar Proteinosis
Date of disclosure of the study information 2013/06/01
Last modified on 2020/12/03

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Basic information
Public title A Study on the Genetics of Autoimmune Alveolar Proteinosis
Acronym APAP Genetics Study
Scientific Title A Study on the Genetics of Autoimmune Alveolar Proteinosis
Scientific Title:Acronym APAP Genetics Study
Region
Japan

Condition
Condition autoimmune alveolar proteinosis
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To comprehensively explore the susceptibility genes of autoimmune alveolar proteinosis over the whole genome
Basic objectives2 Others
Basic objectives -Others A observational study to compare the frequency of single nucleotide polymorphisms in the disease with thatin controls
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes the frequency of a given single nucleotide polymorphism
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
13 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with autoimmune alveolar proteinosis who have anti-GM-CSF autoantibody in serum
Key exclusion criteria 1) patients younger than 13-year-old
2) adult patients who do not have assent ability.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Etsuro
Middle name
Last name Yamaguchi
Organization Aichi Medical University
Division name School of Medicine, Division of Respiratory Medicine and Allergology
Zip code 480-1195
Address Karimata 1-1, Yazako, Nagakute, Aichi
TEL 0561-62-3311
Email etsuro@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name Etsuro
Middle name
Last name Yamaguchi
Organization Aichi Medical University
Division name School of Medicine, Division of Respiratory Medicine and Allergology
Zip code 480-1195
Address Karimata 1-1, Yazako, Nagakute, Aichi
TEL 0561-62-3311
Homepage URL
Email etsuro@aichi-med-u.ac.jp

Sponsor
Institute Aichi Medical University
Osaka University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Aichi Medical University
Address Karimata 1-1, Yazako, Nagakute, Aichi, Japan
Tel 0561-62-3311
Email syomu@aichi-med-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 愛知医科大学
国立病院機構近畿中央呼吸器センター
新潟大学医歯学総合病院
東京医科歯科大学
東京慈恵会医科大学
大阪大学大学院
大阪大学大学院
北海道大学大学院
東北大学大学院
筑波大学
千葉大学
東京医科大学八王子医療センター
さいたま赤十字病院
東京医科大学
杏林大学医学部附属病院
長崎大学熱帯医学研究所
長崎大学病院
鹿児島大学大学院
五島医院
静岡市立静岡病院
細谷クリニック
三重中央医療センター
刈谷豊田総合病院
福島県立医科大学
藤田保健衛生大学
浜松医科大学
神戸市立医療センター中央市民病院
京都大学
倉敷市立児島市民病院
聖隷三方原病院

Other administrative information
Date of disclosure of the study information
2013 Year 06 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
2013 Year 01 Month 15 Day
Date of IRB
2013 Year 01 Month 15 Day
Anticipated trial start date
2013 Year 02 Month 02 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
2023 Year 03 Month 31 Day
Date trial data considered complete
2024 Year 04 Month 30 Day
Date analysis concluded
2024 Year 09 Month 30 Day

Other
Other related information A genome-wide association study to compare the frequency of single nucleotide polymorphisms and whole genome seuences in the disease with those in controls.

Management information
Registered date
2013 Year 05 Month 29 Day
Last modified on
2020 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012646

Research Plan
Registered date File name
2017/06/01 APAPGWAS研究計画書(H28. 6月).docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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