UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057532 |
|---|---|
| Receipt number | R000064328 |
| Scientific Title | Study on the Prediction and Diagnosis of Immune-Related Pneumonia |
| Date of disclosure of the study information | 2025/04/08 |
| Last modified on | 2025/04/06 19:39:41 |
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Basic information
Public title
Study on the Prediction and Diagnosis of Immune-Related Pneumonia
Acronym
Study on the Prediction and Diagnosis of Immune-Related Pneumonia
Scientific Title
Study on the Prediction and Diagnosis of Immune-Related Pneumonia
Scientific Title:Acronym
Study on the Prediction and Diagnosis of Immune-Related Pneumonia
Region
| Japan |
Condition
Condition
Immune-Related Pneumonia
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Pneumology | Hematology and clinical oncology | Surgery in general |
| Gastrointestinal surgery | Chest surgery | Obstetrics and Gynecology |
| Dermatology | Oto-rhino-laryngology | Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to analyze factors involved in the prediction and diagnosis of immune-related pneumonia, aiming to improve monitoring and diagnostic accuracy. As the range of indications for immune checkpoint inhibitors is expected to expand further, the insights gained from this study are anticipated to play a significant role in future cancer treatment.
Basic objectives2
Others
Basic objectives -Others
The objective of this study is to analyze factors involved in the prediction and diagnosis of immune-related pneumonia, aiming to improve monitoring and diagnostic accuracy. This involves analyzing related biomarkers and clinical data to evaluate their utility.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of clinical factors associated with immune-related pneumonia.
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
1.Retrospective observational study:
Patients diagnosed with malignant tumors at Hamamatsu University Hospital who started immune checkpoint inhibitor (ICI) therapy as part of routine clinical care between September 2014 and March 31, 2024.
2.Patients enrolled in one or more of the following studies:
Clinical Features and Outcomes of Pneumonitis related Anti-Programmed Death-1 therapy in Non-Small Cell Lung Cancer Patients (Study No. 18-205)
Six-week oral prednisolone therapy for immune-related pneumonitis: a single-arm phase II study (Study No. 19-037)
Immune checkpoint inhibitor-associated pneumonitis in patients with thoracic malignancy: Multicenter prospective observational study (Study No. 19-049)
Key exclusion criteria
Patients (or their representatives) who have withdrawn or refused consent for the use of their information in this study.
Patients who did not develop immune-related pneumonitis (irP) and received two or fewer courses of immune checkpoint inhibitors (ICI).
Target sample size
800
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 Ward, Hamamatsu, Shizuoka
TEL
053-435-2263
Suda@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 Ward, Hamamatsu, Shizuoka
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
Japan
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, Ward, Hamamatsu, Shizuoka
Tel
053-435-2111
hama-med@esct.bvits.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 08 | 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
843
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
| 2024 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 03 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2028 | 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 retrospective observational study aimed at analyzing data from patients treated with immune checkpoint inhibitors to improve the prediction and diagnostic accuracy of immune-related pneumonitis.
Management information
Registered date
| 2025 | Year | 04 | Month | 06 | Day |
Last modified on
| 2025 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064328
