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
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
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
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
