UMIN-CTR Clinical Trial

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
Email	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
Email	tyoguma@db4.so-net.ne.jp

Sponsor
Institute	Japan Agency for Medical Research and Development
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014136