UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061119 |
|---|---|
| Receipt number | R000069942 |
| Scientific Title | A Multicenter Cohort Study to Identify Risk Factors for Fibrosis in Autoimmune Pulmonary Alveolar Proteinosis |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/31 22:29:27 |
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Basic information
Public title
A cohort study investigating the risk of fibrosis in autoimmune alveolar proteinosis
Acronym
A cohort study investigating the risk of fibrosis in autoimmune alveolar proteinosis
Scientific Title
A Multicenter Cohort Study to Identify Risk Factors for Fibrosis in Autoimmune Pulmonary Alveolar Proteinosis
Scientific Title:Acronym
A Multicenter Cohort Study to Identify Risk Factors for Fibrosis in Autoimmune Pulmonary Alveolar Proteinosis
Region
| Japan |
Condition
Condition
Autoimmune Pulmonary Alveolar Proteinosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the clinical characteristics and prognostic factors associated with cases that do or do not develop pulmonary fibrosis in Autoimmune Pulmonary Alveolar Proteinosis.
Basic objectives2
Others
Basic objectives -Others
To identify the clinical characteristics of cases that develop progressive pulmonary fibrosis.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
An Investigation into the Clinical Characteristics of Cases Presenting with Pulmonary Fibrosis
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants must meet all of the following criteria (1) through (3):
1) Patients with autoimmune alveolar proteinosis who participated in the PAGE trial
2) Patients for whom retrospective review of clinical data is possible at each participating institution
3) Patients currently receiving outpatient care at a participating institution who, after receiving a thorough explanation regarding participation in this study and demonstrating full understanding, have provided written informed consent of their own free will
Key exclusion criteria
Individuals who meet any of the following criteria:
1) Individuals who have expressed their refusal to participate in this study through the disclosure documents
2) Individuals whom the principal investigator deems unsuitable for other reasons
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Suzuki |
Organization
Chiba University Hospital
Division name
Department of Respirology
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba, Chiba, Japan
TEL
043-222-7171
suzutaku@chiba-u.jp
Public contact
Name of contact person
| 1st name | Ryutaro |
| Middle name | |
| Last name | Hirama |
Organization
Chiba University Hospital
Division name
Department of Respirology
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba, Chiba, Japan
TEL
043-222-7171
Homepage URL
ryu.154038@gmail.com
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
none
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
Chiba University Hospital Observational Research Ethics Review Board
Address
1-8-1, Inohana, Chuo-ku, Chiba, Chiba, Japan
Tel
043-222-7171
hsp-kansaturinri@chiba-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
Other administrative information
Date of disclosure of the study information
| 2026 | 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
| 2026 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 09 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The samples and information collected and used in this study are as follows.
Blood: Stored serum collected at the time of the PAGE test.
For participants who have provided informed consent, an additional 10 mL of blood will be collected during routine peripheral venous blood collection.
Information: The following existing clinical information will be collected from the medical records of each research institution.
A) Patient background: Age, sex, respiratory-related complications, smoking history, exposure to secondhand smoke, occupational history, history of dust exposure (occupational, residential, or disaster-related), past medical history and comorbidities, concomitant medications, family history, subjective symptoms, and use of home oxygen therapy (oxygen flow rate)
B) Information on pulmonary alveolar proteinosis: Time of onset (diagnosis), diagnostic method, treatment history (inhaled GM-CSF therapy, lung lavage [whole lung or segmental], symptomatic treatment), duration of illness, outcome and prognosis
C) Test items: Blood tests, arterial blood gas analysis, imaging studies, pulmonary function tests, 6-minute walk test, QOL questionnaire, imaging studies
Management information
Registered date
| 2026 | Year | 03 | Month | 31 | Day |
Last modified on
| 2026 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069942
