UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038966 |
|---|---|
| Receipt number | R000044375 |
| Scientific Title | Japanese registry for lymphangioleiomyomatosis and alpha1-antitrypsin deficiency |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2022/12/26 10:10:28 |
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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
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
kseyama@juntendo.ac.jp
Sponsor or person
Institute
Division of Respiratory Medicine
Juntendo University Faculty of Medicine & Graduate School of Medicine
Institute
Department
Personal name
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
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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 27 | 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
| 2022 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.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 |
