UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032470 |
|---|---|
| Receipt number | R000037024 |
| Scientific Title | Malutiple-institutional observational surveillance of Pembrolizumab as a first line treatment for non-small cell lung cancer |
| Date of disclosure of the study information | 2018/05/04 |
| Last modified on | 2018/05/04 15:17:53 |
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Basic information
Public title
Malutiple-institutional observational surveillance of Pembrolizumab as a first line treatment for non-small cell lung cancer
Acronym
Observational surveillance of Pembrolizumab as a 1st line treatment for NSCLC
Scientific Title
Malutiple-institutional observational surveillance of Pembrolizumab as a first line treatment for non-small cell lung cancer
Scientific Title:Acronym
Observational surveillance of Pembrolizumab as a 1st line treatment for NSCLC
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 investigate of factors influencing the response rate and adverse reactions to an immune checkpoint inhibitor, as well as subsequent therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate whether obsertive analysis of nivolumab therapy in the real clinical setting reproduces the RR shown by primary analysis of the KeyNote-024 trial.
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
1) Patients with a definite diagnosis of NSCLC based on histology or cytology.
2) Patients unsuitable for curative radiation therapy who have a clinical diagnosis of either recurrent disease or stage IV NSCLC.
3) Patients who receive at least one dose of pembrolizumab.
Key exclusion criteria
1)Patients who have previously received pembrolizumab in a clinical trial will be excluded
2)Pretreated chemotherapy
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tamiya Motohiro |
Organization
Osaka International Cancer Institute
Division name
Thoracic Oncology
Zip code
Address
3-1-69 Otemae Chuo-ku Osaka
TEL
06-6945-1181
moto19781205@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fujimoto Daichi |
Organization
Kobe City Medical Center General Hospital
Division name
Respiratory Medicine
Zip code
Address
2-1-1 Minatojimaminamicho Chuo-ku Kobe
TEL
078-302-4321
Homepage URL
daichianzen@yahoo.co.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
Osaka International Cancer Institute
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
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
独立行政法人国立病院機構近畿中央胸部疾患センター 大阪はびきの医療センター
神戸市立医療センター中央市民病院
兵庫県立尼崎総合医療センター
公益財団法人大原記念倉敷中央医療機構 倉敷中央病院神戸市立医療センター西市民病院
独立行政法人国立病院機構 姫路医療センター
大阪国際がんセンター
独立行政法人国立病院機構 刀根山病院
大阪急性期総合医療センター
市立伊丹病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Case control study. We will assess clinical demographic, diagnosis, histological subtypes, treatment of pembrolizumab, clinical outcome (response, time-to-event), or laboratory data.
Management information
Registered date
| 2018 | Year | 05 | Month | 04 | Day |
Last modified on
| 2018 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037024
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
