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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038966
Receipt No. R000044375
Scientific Title Japanese registry for lymphangioleiomyomatosis and alpha1-antitrypsin deficiency
Date of disclosure of the study information 2020/04/01
Last modified on 2019/12/24

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Basic information
Public title Japanese registry for lymphangioleiomyomatosis and alpha1-antitrypsin deficiency
Acronym J-LAM/AATD
Scientific Title Japanese registry for lymphangioleiomyomatosis and alpha1-antitrypsin deficiency
Scientific Title:Acronym J-LAM/AATD
Region
Japan

Condition
Condition lymphangioleiomyomatosis and alpha1-antitrypsin deficiency
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To accumulate clinical information of patients with lymphangioleiomyomatosis or alpha1-antitrypsin deficiency and evaluate the outcomes and contribute the development of the new treatment for both diseases.
Basic objectives2 Others
Basic objectives -Others nothing particular
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Assessment of the clinical information from the patients with lymphangioleiomyomatosis and alpha1-antitrypsin deficiency every 5 years.
Key secondary outcomes Alive or not.
Health Questionnaire (EQ-5D-5L)
The progressive rate of pulmonry function for the patients with lymphangioleiomyomatosis and alpha1-antitrypsin deficiency

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
20 years-old <=
Age-upper limit
120 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients diagnosed with LAM or AATD
2) Patients obtained informed consent
Key exclusion criteria 1) Patients who are not able to make a decision about entry to this research
2) Patients who are not eligible for entry to this research
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Kuniaki
Middle name
Last name Seyama
Organization Juntendo University Faculty of Medicine & Graduate School of Medicine
Division name Division of Respiratory Medicine
Zip code 113-8431
Address 3-1-3 Hongo Bunkyo-Ku Tokyo
TEL 0358021063
Email kseyama@juntendo.ac.jp

Public contact
Name of contact person
1st name Kuniaki
Middle name
Last name Seyama
Organization Juntendo University Faculty of Medicine & Graduate School of Medicine
Division name Division of Respiratory Medicine
Zip code 113-8431
Address 3-1-3 Hongo Bunkyo-Ku Tokyo
TEL 0358021063
Homepage URL
Email kseyama@juntendo.ac.jp

Sponsor
Institute Division of Respiratory Medicine
Juntendo University Faculty of Medicine & Graduate School of Medicine
Institute
Department

Funding Source
Organization 1.Japanese Respiratory Foundation
2.Japan Agency for Medical Research and Development(AMED)
3.Ministry of Health, Labour and Welfare
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 Division of Respiratory Medicine Juntendo University Faculty of Medicine & Graduate School of Medicine
Address 3-1-3 Hongo Bunkyo-Ku Tokyo
Tel 0358021063
Email kseyama@juntendo.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
2020 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 Preinitiation
Date of protocol fixation
2019 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2025 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Nothing particular

Management information
Registered date
2019 Year 12 Month 24 Day
Last modified on
2019 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044375

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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