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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033826
Receipt No. R000038580
Scientific Title A retrospective analysis for the predictive factors for severe adverse event in the patients of advanced non-small cell lung cancer who treated with anti-PD-1 antibody
Date of disclosure of the study information 2018/08/20
Last modified on 2020/04/21

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Basic information
Public title A retrospective analysis for the predictive factors for severe adverse event in the patients of advanced non-small cell lung cancer who treated with anti-PD-1 antibody
Acronym Adverse events of anti-PD-1 antibody and predictive factors in patients with lung cancer
Scientific Title A retrospective analysis for the predictive factors for severe adverse event in the patients of advanced non-small cell lung cancer who treated with anti-PD-1 antibody
Scientific Title:Acronym Adverse events of anti-PD-1 antibody and predictive factors in patients with lung cancer
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To identify predictive factors for severe adverse events of anti-PD-1 antibody in patients with advanced non-small cell lung cancer.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes incidence of severe adverse events
Key secondary outcomes response rate, progression-free survival

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 in whom NSCLC had been histologically diagnosed from January 2016 to February 2018 at Kansai Medical University Medical Center and treated with anti-PD-1 antibody.
Key exclusion criteria Patients refused to participate of this study, judged as inappropriate by principal investigator.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Tamaki
Organization Kansai Medical University Medical Center
Division name First Department of Internal Medicine
Zip code
Address Fumizono-cho 10-15, Moriguchi-city, Osaka.
TEL 06-6992-1001
Email tamakit@takii.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Tamaki
Organization Kansai Medical University Medical Center
Division name First Department of Internal Medicine
Zip code
Address Fumizono-cho 10-15, Moriguchi-city, Osaka.
TEL 06-6992-1001
Homepage URL
Email tamakit@takii.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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 08 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 No longer recruiting
Date of protocol fixation
2018 Year 05 Month 01 Day
Date of IRB
2018 Year 05 Month 01 Day
Anticipated trial start date
2018 Year 08 Month 21 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective study
All the patients met the criteria for selection, in whom NSCLC had been histologically diagnosed from January 2016 to February 2018 at Kansai Medical University Medical Center and treated with anti-PD-1 antibody.

Management information
Registered date
2018 Year 08 Month 20 Day
Last modified on
2020 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038580

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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