UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033826 |
|---|---|
| Receipt number | 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 | 2022/08/23 11:24:05 |
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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 | Takeshi |
| Middle name | |
| Last name | Tamaki |
Organization
Kansai Medical University Medical Center
Division name
First Department of Internal Medicine
Zip code
570-8507
Address
Fumizono-cho 10-15, Moriguchi-city, Osaka.
TEL
06-6992-1001
tamakit@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Tamaki |
Organization
Kansai Medical University Medical Center
Division name
First Department of Internal Medicine
Zip code
570-8507
Address
Fumizono-cho 10-15, Moriguchi-city, Osaka.
TEL
06-6992-1001
Homepage URL
tamakit@takii.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
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
The Ethics Review Board of Kansai Medical University Medical Center
Address
Fumizono-cho 10-15, Moriguchi-city, Osaka.
Tel
06-6992-1001
kouhou@takii.kmu.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
| 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
60
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
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 11 | Month | 30 | Day |
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
| 2022 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038580
