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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035125
Receipt No. R000040036
Official scientific title of the study 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

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Basic information
Official scientific title of the study Immunological mechanism and correspondent antigen of anti PD-1/PD-L1 antibody Related lung adverse events
Title of the study (Brief title) 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 Ou Yamaguchi
Organization Saitama Medical University International Medical Center
Division name Respiratory medicine
Address Yamane, Hidaka city, Saitama
TEL 042-984-4111
Email ouyamagu@saitama-med.ac.jp

Public contact
Name of contact person Ou Yamaguchi
Organization Saitama Medical University International Medical Center
Division name Respiratory medicine
Address Yamane, Hidaka city, Saitama
TEL 042-984-4111
Homepage URL
Email ouyamagu@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University International Medical Center
Institute
Department

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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 04 Month 14 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040036

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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