UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039761 |
|---|---|
| Receipt number | R000045349 |
| Scientific Title | Immune checkpoint inhibitor-associated pneumonitis in patients with thoracic malignancy: Multicenter prospective observational study |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2020/03/10 21:51:03 |
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Basic information
Public title
Immune checkpoint inhibitor-associated pneumonitis in patients with thoracic malignancy: Multicenter prospective observational study
Acronym
Immune checkpoint inhibitor-associated pneumonitis: Multicenter prospective observational study
Scientific Title
Immune checkpoint inhibitor-associated pneumonitis in patients with thoracic malignancy: Multicenter prospective observational study
Scientific Title:Acronym
Immune checkpoint inhibitor-associated pneumonitis: Multicenter prospective observational study
Region
| Japan |
Condition
Condition
thoracic malignancy
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify incidence and risk factors of immune checkpoint inhibitor-associated pneumonitis in patients with thoracic malignancy in clinical practice.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of immune checkpoint inhibitor-associated pneumonitis
Key secondary outcomes
Risk factors for the development of immune checkpoint inhibitor-associated pneumonitis
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with thoracic malignancy who will receive nivolumab or pembrolizumab or atezolizumab
Key exclusion criteria
nothing
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, Higashi Ward, Hamamatsu, Shizuoka
TEL
053-435-2111
Suda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Koyauchi |
Organization
Hamamatsu University School of Medicine
Division name
Second Division, Department of Internal Medicine
Zip code
431-3192
Address
1-20-1 Handayama, Higashi Ward, Hamamatsu, Shizuoka
TEL
053-435-2111
Homepage URL
t.koya@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, Higashi 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
| 2020 | 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
| 2019 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective observational study investigating the incidence of pneumonitis and risk factors in patients using nivolumab, pembrolizumab, or atezolizumab.
Management information
Registered date
| 2020 | Year | 03 | Month | 10 | Day |
Last modified on
| 2020 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045349
