UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025908 |
|---|---|
| Receipt number | R000029772 |
| Scientific Title | Retrospective cohort study of correlation between immune check point molecular inhibitor and response factor, side effect, and post treatment |
| Date of disclosure of the study information | 2017/01/31 |
| Last modified on | 2017/03/26 20:34:28 |
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Basic information
Public title
Retrospective cohort study of correlation between immune check point molecular inhibitor and response factor, side effect, and post treatment
Acronym
The rerashonship between immune check point molecular inhibitor and response factor, side effect, or post treatment
Scientific Title
Retrospective cohort study of correlation between immune check point molecular inhibitor and response factor, side effect, and post treatment
Scientific Title:Acronym
The rerashonship between immune check point molecular inhibitor and response factor, side effect, or post treatment
Region
| Japan |
Condition
Condition
Patients with non-resectable advanced or recurrent NSCLC receiving treatment with nivolumab
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
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
Others
Basic objectives -Others
A: Relation between pretreatment patient characteristics and the efficacy of nivolumab and its ARs.
B: Response patterns, sites of response (anatomical regions), and ARs
C: Influence of nivolumab on subsequent treatment
D: Correlation with effect of nivolumab and IHC of PD-L1
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To investigate whether retrospective analysis of nivolumab therapy in the real clinical setting reproduces the RR shown by primary analysis of the CheckMate trial.
Key secondary outcomes
A: Relation between pretreatment patient characteristics and the efficacy of nivolumab and its ARs.
B: Response patterns, sites of response (anatomical regions), and ARs
C: Influence of nivolumab on subsequent treatment
D: Correlation with effect of nivolumab and IHC of PD-L1
Base
Study type
Others,meta-analysis etc
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 nivolumab.
Key exclusion criteria
Patients who have previously received nivolumab in a clinical trial will be excluded
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Imamura Fumio |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Thoracic Oncology
Zip code
Address
1-3-3 Nakamichi, Higashinari-ku, Osaka
TEL
06-6972-1181
imamura-fu@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tamiya Motohiro |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Thoracic Oncology
Zip code
Address
1-3-3 Nakamichi, Higashinari-ku, Osaka
TEL
06-6972-1181
Homepage URL
moto19781205@yahoo.co.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD.
Bristol-Myers Squibb K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Hospital Organization Kinki Chuo Chest Medical Center
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 31 | 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
| 2016 | Year | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary endpoint:
To investigate whether retrospective analysis of nivolumab therapy in the real clinical setting reproduces the RR shown by primary analysis of the CheckMate trial.
Secondary endpoints:
A: Relation between pretreatment patient characteristics and the efficacy of nivolumab and its ARs.
B: Response patterns, sites of response (anatomical regions), and ARs
C: Influence of nivolumab on subsequent treatment
D: Correlation with effect of Nivolumab and IHC of PD-L1
Management information
Registered date
| 2017 | Year | 01 | Month | 30 | Day |
Last modified on
| 2017 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029772
| 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 |
