UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012101 |
|---|---|
| Receipt number | R000014136 |
| Scientific Title | Allergic bronchopulmonary mycosis research registry |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2021/10/28 17:12:09 |
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Basic information
Public title
Allergic bronchopulmonary mycosis research registry
Acronym
ABPM research registry
Scientific Title
Allergic bronchopulmonary mycosis research registry
Scientific Title:Acronym
ABPM research registry
Region
| Japan |
Condition
Condition
Allergic bronchopulmonary mycosis
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Registry and clinical analysis of cases with allergic bronchopulmonary mycosis (ABPM) to establish Japanese guideline of ABPM
Basic objectives2
Others
Basic objectives -Others
Observation study of clinical history/QOL/prognosis and accumulation of blood samples from ABPM patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clinical history/QOL/prognosis/fungus-specific antibody in serum/fungi in sputa/et al.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. ABPM or related diseases
A. Allergic bronchopulmonary aspergillosis
B. non-Aspergillus ABPM
C. mucus plug in bronchus
D. bronchocentric granulomatosis
2. controls
E. Aspergilloma
F. severe asthma
G. Healthy subjects
Key exclusion criteria
none
Target sample size
370
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Asano |
Organization
Tokai University School of Medicine
Division name
Division of Pulmonary Medicine
Zip code
2591193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
ko-asano@tokai-u.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Oguma |
Organization
Tokai University School of Medicine
Division name
Division of Pulmonary Medicine
Zip code
2591193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
Homepage URL
tyoguma@db4.so-net.ne.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokai University School of Medicine
Address
143 Shimokasuya, Isehara, Kanagawa
Tel
0463-93-1121
tokai-rinsho@ml.tokai-u.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
東海大学医学部付属病院（神奈川県）、 国立病院機構相模原病院（神奈川県）、国立病院機構福岡病院（福岡県）、千葉大学真菌医学研究センター（千葉県）、長崎大学病院（長崎県）、北海道大学病院（北海道）、慶應義塾大学病院（東京都）、東邦大学大橋医療センター（東京都）、国立病院機構東京病院（東京都）、埼玉県立循環器呼吸器病センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | 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
250
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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective registry research
Management information
Registered date
| 2013 | Year | 10 | Month | 22 | Day |
Last modified on
| 2021 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014136
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
