UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043974 |
|---|---|
| Receipt number | R000050228 |
| Scientific Title | A multicenter retrospective study investigating the safety and efficacy of immune checkpoint inhibitors in lung cancer with interstitial pneumonia |
| Date of disclosure of the study information | 2021/04/20 |
| Last modified on | 2021/10/19 13:15:38 |
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Basic information
Public title
A multicenter retrospective study investigating the safety and efficacy of immune checkpoint inhibitors in lung cancer with interstitial pneumonia
Acronym
A multicenter retrospective study investigating the safety and efficacy of immune checkpoint inhibitors in lung cancer with interstitial pneumonia
Scientific Title
A multicenter retrospective study investigating the safety and efficacy of immune checkpoint inhibitors in lung cancer with interstitial pneumonia
Scientific Title:Acronym
A multicenter retrospective study investigating the safety and efficacy of immune checkpoint inhibitors in lung cancer with interstitial pneumonia
Region
| Japan |
Condition
Condition
Lung cancer with interstitial pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We retrospectively examine the safety and efficacy of immune checkpoint inhibitors in primary lung cancer with interstitial pneumonia.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of drug-induced lung injury as an immune-related adverse event and rate of serious adverse events in patients treated with immune checkpoint inhibitors for primary lung cancer with interstitial pneumonia
Key secondary outcomes
1) Response rate of immune checkpoint inhibitors
2) Progression-free survival
3) Overall survival
4) Duration of treatment
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) Patients diagnosed with primary lung cancer
2) Patients with interstitial pneumonia
3) Patients who received immune checkpoint inhibitors
Key exclusion criteria
1) Radiation pneumonia
2) Drug-induced pneumonia
3) Interstitial lung abnormality
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuma |
| Middle name | |
| Last name | Kishi |
Organization
Toho University School of Medicine
Division name
Division of Respiratory Medicine
Zip code
143-8542
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo, Japan
TEL
03-3762-4151
kazuma.kishi@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazutoshi |
| Middle name | |
| Last name | Isobe |
Organization
Toho University School of Medicine
Division name
Division of Respiratory Medicine
Zip code
143-8542
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo, Japan
TEL
03-3762-4151
Homepage URL
kazutoshiisobe@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
the Ministry of Health, Labour and Welfare of Japan awarded to the Study Group on Diffuse Pulmonary Disorders, Scientific Research/Research on intractable disease.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toho University School of Medicine Ethics Committee
Address
6-11-1 Omori-Nishi, Ota-ku, Tokyo, Japan
Tel
03-3762-4151
med.rinri@ext.toho-u.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
| 2021 | Year | 04 | Month | 20 | 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
| 2021 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2021 | Year | 04 | Month | 19 | Day |
Last modified on
| 2021 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050228
