UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010835
Receipt number 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 12:46:41

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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 or person

Institute

Aichi Medical University
Osaka University

Institute

Department

Personal name



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

Value
https://center6.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