UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061510 |
|---|---|
| Receipt number | R000069927 |
| Scientific Title | A Prospective Observational Study on the Utility of Rapid GM-CSF Autoantibody Testing (LineCheck APAP) in Patients with Undiagnosed Diffuse Pulmonary Ground-Glass Opacities |
| Date of disclosure of the study information | 2026/05/30 |
| Last modified on | 2026/04/01 19:32:14 |
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Basic information
Public title
A Prospective Observational Study on the Utility of Rapid GM-CSF Autoantibody Testing (LineCheck APAP) in Patients with Undiagnosed Diffuse Pulmonary Ground-Glass Opacities
Acronym
RAPIDXGGO Study
Scientific Title
A Prospective Observational Study on the Utility of Rapid GM-CSF Autoantibody Testing (LineCheck APAP) in Patients with Undiagnosed Diffuse Pulmonary Ground-Glass Opacities
Scientific Title:Acronym
RAPIDXGGO Study
Region
| Japan |
Condition
Condition
Undiagnosed diffuse lung diseases presenting with diffuse ground-glass opacities on HRCT
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate whether rapid qualitative assay for GM-CSF autoantibodies using KBM LineCheck APAP at the initial visit contributes to early diagnosis of autoimmune pulmonary alveolar proteinosis (APAP) and to assess the diagnostic utility of the test in patients with unconfirmed diffuse lung diseases (DLDs) presenting with diffuse ground-glass opacities (GGOs) on HRCT.
Basic objectives2
Others
Basic objectives -Others
Evaluation of diagnostic performance and utility
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Co-primary outcomes assessed within 6 months after registration are: 1) the positivity rate of rapid GM-CSF autoantibody test in patients with unexplained diffuse GGOs, 2) the proportion of patients with final diagnosis of APAP among GM-CSF antibody-positive cases (positive predictive value), and 3) the negative predictive value of the test among GM-CSF antibody-positive cases.
Key secondary outcomes
1) Descriptive analysis of the clinical characteristics of GM-CSF antibody-positive patients, 2) establishment and storage of a specimen repository, and 3) comparison between the results of KBM LineCheck APAP and quantitative GM-CSF antibody levels measured by ELISA.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients evaluated or treated at Kumamoto University Hospital, Kyoto University Hospital, Kyorin University Hospital, Institute of Science Tokyo Hospital, Chiba University Hospital, Saitama Red Cross Hospital, or Tohoku University Hospital; 2) 18 years and older; 3) undiagnosed DLDs presenting with diffuse GGOs on HRCT at the initial visit; and 4) patients who received a written explanation of the study and provided written informed consent.
Key exclusion criteria
1) Patients with an obvious mass lesion or localized nodular lesion; 2) patients with an acute clinical course showing rapid progression within 1 month; 3) patients with an already identified cause of DLD, such as drug-induced lung injury; 4) patients with overt cardiac disease causing pulmonary congestion, such as heart failure; 5) cases judged to be inappropriate for participation by the treating physician at the time of HRCT assessment; and 6) patients currently participating in another interventional study that precludes participation in this study.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Takuro |
| Middle name | |
| Last name | Sakagami |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Respiratory Medicine
Zip code
860-0811
Address
1-1-1 Honjo, Chuo-ku, Kumamoto 860-0811, Japan
TEL
096-373-5012
stakuro@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kimitaka |
| Middle name | |
| Last name | Akaike |
Organization
Kumamoto University Hospital
Division name
Department of Respiratory Medicine
Zip code
860-0811
Address
1-1-1 Honjo, Chuo-ku, Kumamoto 860-0811, Japan
TEL
+81963635012
Homepage URL
demio0601@gmail.com
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Kojin Bio Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyoto University Hospital (Kyoto), Kyorin University Hospital (Tokyo), Institute of Science Tokyo Hospital (Tokyo), Chiba University Hospital (Chiba), Saitama Red Cross Hospital (Saitama), and Tohoku University Hospital (Miyagi)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kumamoto University Hospital
Address
1-1-1 Honjo, Chuo-ku, Kumamoto 860-0811, Japan
Tel
096-373-5012
demio0601@gmail.com
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
熊本大学病院（熊本県）、京都大学医学部附属病院（京都府）、杏林大学医学部付属病院（東京都）、東京科学大学病院（東京都）、千葉大学医学部附属病院（千葉県）、さいたま赤十字病院（埼玉県）、東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 30 | 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
| 2026 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter prospective observational study with no intervention. Consecutive newly presenting patients with diffuse GGO on HRCT will be prospectively enrolled at participating institutions from the date of institutional approval through March 31, 2028, if they meet the inclusion criteria and none of the exclusion criteria. Clinical information, blood tests, chest radiography, HRCT, and pulmonary function tests will be collected within routine clinical practice, and results of BAL, cryobiopsy, and surgical lung biopsy will be collected when clinically indicated. An additional 10 mL serum sample will be collected for research use to perform rapid qualitative testing with KBM Linecheck APAP and quantitative measurement of GM-CSF autoantibodies by ELISA. Primary evaluation will be based on the final diagnosis established within 6 months after registration.
Management information
Registered date
| 2026 | Year | 05 | Month | 10 | Day |
Last modified on
| 2026 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069927
