UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035125 |
|---|---|
| Receipt number | R000040036 |
| Scientific Title | Immunological mechanism and correspondent antigen of anti PD-1/PD-L1 antibody Related lung adverse events |
| Date of disclosure of the study information | 2018/12/03 |
| Last modified on | 2018/12/03 23:58:38 |
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Basic information
Public title
Immunological mechanism and correspondent antigen of anti PD-1/PD-L1 antibody Related lung adverse events
Acronym
IR-Lung study
Scientific Title
Immunological mechanism and correspondent antigen of anti PD-1/PD-L1 antibody Related lung adverse events
Scientific Title:Acronym
IR-Lung study
Region
| Japan |
Condition
Condition
non-small-cell lung cancer
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the responsible T cell fraction of onset pulmonary adverse events by anti PD-1 / PD-L1 antibody therapy
Basic objectives2
Others
Basic objectives -Others
Establishment of immunological biomarkers for pulmonary adverse events
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To elucidate the responsible T cell fraction of onset pulmonary adverse events by anti PD-1 / PD-L1 antibody therapy
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who had anti-PD-1/PD-L1 antibody treatment in patients with advanced non-small cell lung cancer
2. Patients who appeared new pulmonary abnormal shadows that did not appear in chest CT before treatment during anti-PD-1/PD-L1 antibody treatment
3. Patient who gets written consent form
Key exclusion criteria
1. Patients who have judged that their participation in this study is inappropriate
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ou Yamaguchi |
Organization
Saitama Medical University International Medical Center
Division name
Respiratory medicine
Zip code
Address
Yamane, Hidaka city, Saitama
TEL
042-984-4111
ouyamagu@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ou Yamaguchi |
Organization
Saitama Medical University International Medical Center
Division name
Respiratory medicine
Zip code
Address
Yamane, Hidaka city, Saitama
TEL
042-984-4111
Homepage URL
ouyamagu@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University International Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 12 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 04 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 12 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Flow cytometric analysis of PBMC and bronchoalveolar lavage fluid is performed for patients with pulmonary disorder.
Management information
Registered date
| 2018 | Year | 12 | Month | 03 | Day |
Last modified on
| 2018 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040036
