UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060291 |
|---|---|
| Receipt number | R000068967 |
| Scientific Title | Utility of Interstitial Pneumonia Biomarkers in the Differential Diagnosis of Immune Checkpoint Inhibitor-Related Pneumonitis |
| Date of disclosure of the study information | 2026/01/07 |
| Last modified on | 2026/01/07 21:09:27 |
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Basic information
Public title
Utility of Interstitial Pneumonia Biomarkers in the Differential Diagnosis of Immune Checkpoint Inhibitor-Related Pneumonitis
Acronym
Utility of Interstitial Pneumonia Biomarkers in the Differential Diagnosis of Immune Checkpoint Inhibitor-Related Pneumonitis
Scientific Title
Utility of Interstitial Pneumonia Biomarkers in the Differential Diagnosis of Immune Checkpoint Inhibitor-Related Pneumonitis
Scientific Title:Acronym
Utility of Interstitial Pneumonia Biomarkers in the Differential Diagnosis of Immune Checkpoint Inhibitor-Related Pneumonitis
Region
| Japan |
Condition
Condition
Immune checkpoint inhibitor-related pneumonitis and other newly developed acute pulmonary diseases in cancer patients
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Pneumology | Hematology and clinical oncology | Infectious disease |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Chest surgery |
| Breast surgery | Obstetrics and Gynecology | Dermatology |
| Oto-rhino-laryngology | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of KL-6 and SP-D in the differential diagnosis between immune checkpoint inhibitor-related pneumonitis and other pulmonary diseases presenting with lung lesions.
Basic objectives2
Others
Basic objectives -Others
To evaluate the diagnostic performance and cutoff values of serum KL-6 and SP-D in the differential diagnosis between immune checkpoint inhibitor-related pneumonitis and other pulmonary diseases.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Determination of optimal cutoff values for KL-6 and SP-D in the differential diagnosis between immune checkpoint inhibitor-related pneumonitis and other pulmonary disease.
Diagnostic accuracy of KL-6 and SP-D when their established normal upper limits are used as cutoff values.
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
Retrospective observational study:
Patients who were diagnosed with malignant tumors at Hamamatsu University School of Medicine Hospital and initiated immune checkpoint inhibitor therapy as part of routine clinical practice between September 2014 and March 2025, and who were subsequently diagnosed with immune checkpoint inhibitor-related pneumonitis.
In addition, patients who received clinical care for newly developed pulmonary lesions during the same period (September 2014 to March 2025).
Pooled analysis:
Patients registered in the following studies approved by the Institutional Review Board of Hamamatsu University School of Medicine (Hamamatsu, Japan):
Clinical Features and Outcomes of Pneumonitis related Anti-Programmed Death-1 therapy in Non-Small Cell Lung Cancer Patients (Study No. 19-037)
Six-week oral prednisolone therapy for immune-related pneumonitis: a single-arm phase II study (Study No. 19-037)
Key exclusion criteria
Patients meeting the following criteria will be excluded from the study:
Patients who withdrew or refused consent for the use of their information for this study, either by themselves or through a legally authorized representative.
Patients in whom serum KL-6 and SP-D were not measured.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Suda |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka, Japan
TEL
053-435-2263
41242192@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Nakai |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka, Japan
TEL
053-435-2263
Homepage URL
41242192@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Institutional Review Board of Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Chuo-ku, Hamamatsu, Shizuoka, Japan
Tel
053-435-2680
rinri@hama-med.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
| 2026 | Year | 01 | Month | 07 | 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
200
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
| 2025 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 08 | 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
Single-center, retrospective, observational study
Management information
Registered date
| 2026 | Year | 01 | Month | 07 | Day |
Last modified on
| 2026 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068967
