UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045538 |
|---|---|
| Receipt number | R000051971 |
| Scientific Title | REAL world efficacy and safety analysis of pembrolizumab KEY truda |
| Date of disclosure of the study information | 2021/09/30 |
| Last modified on | 2024/09/24 20:38:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
REAL world efficacy and safety analysis of pembrolizumab KEY truda
Acronym
REAL-KEY trial
Scientific Title
REAL world efficacy and safety analysis of pembrolizumab KEY truda
Scientific Title:Acronym
REAL-KEY trial
Region
| Japan |
Condition
Condition
Patients with non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to collect clinical and prognostic information on lung cancer patients treated with immune checkpoint inhibitor therapy in Japan, in order to understand the actual status of treatment efficacy, adverse events, treatment duration, and survival, and to analyze the predictors of treatment efficacy. .
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 year survival
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All of the following conditions must be met.
1) Patients with non-small cell lung cancer who started treatment with Keytruda (pembrolizumab) between February 1 and June 30, 2017.
(2) Patients with non-small cell lung cancer who agreed with the purpose of this study and received treatment at a facility that conducts post-marketing surveillance based on the "Ministerial Ordinance Partially Amending the Ministerial Ordinance on Standards for Post-marketing Surveillance of Pharmaceuticals (Ministry of Health and Welfare Ordinance No. 151 of 2000)
Key exclusion criteria
No special rules
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Yoshino |
Organization
The Japan Lung Cancer Society
Chiba University Graduate School of Medicine,
Division name
Department of General Thoracic Surgery
Zip code
260-8670
Address
1-8-1, Iohana, Chuo-ku, Chiba-city, Chiba-ken, Japan
TEL
043-222-7171
chiba_thoracic_surgery@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Terai |
Organization
Keio University Hospital
Division name
Clinical and Translational Research Center
Zip code
160-8582
Address
35 Shinanomachi, Shinjukuku, Tokyo, Japan
TEL
0333531211
Homepage URL
ksoejima@keio.jp
Sponsor or person
Institute
Tha Japan Lung Cancer Society
Institute
Department
Personal name
Funding Source
Organization
The Japan Lung Cancer Society
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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjukuku, Tokyo
Tel
0353633503
med-rinri-jimu@adst.keio.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 | 09 | Month | 30 | 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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational Study
Management information
Registered date
| 2021 | Year | 09 | Month | 22 | Day |
Last modified on
| 2024 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051971
