UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023210 |
|---|---|
| Receipt number | R000026757 |
| Scientific Title | prospective observational study to assess efficacy and safety of nivolumab in patients with recurrent non-small cell lung cancer |
| Date of disclosure of the study information | 2016/07/19 |
| Last modified on | 2016/07/18 02:15:11 |
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Basic information
Public title
prospective observational study to assess efficacy and safety of nivolumab in patients with recurrent non-small cell lung cancer
Acronym
prospective observational study to assess efficacy and safety of nivolumab in patients with recurrent non-small cell lung cancer
Scientific Title
prospective observational study to assess efficacy and safety of nivolumab in patients with recurrent non-small cell lung cancer
Scientific Title:Acronym
prospective observational study to assess efficacy and safety of nivolumab in patients with recurrent non-small cell 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
We will reveal appropriate cases for nivolmab in patients with recurrent non-small cell lung cancer, by verifying a correlation between efficacy and safety of this agent and clinical characteristics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
response rate and their clinical profiling
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)adequate patients to administrate nivolmab, after 1st line chemotherapy
2)patients who assent to this study
Key exclusion criteria
1)inadequate patients to administrate nivolmab
2)patients that the investigators identify inadequate for this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyoichi Kaira |
Organization
Gunma University Hospital
Division name
department of translational medicine
Zip code
Address
3-39-15 Maebashi, Gunma, Japan
TEL
027-220-7111
kkaira1970@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinsuke Kitahara |
Organization
Gunma University Hospital
Division name
department of respiratory and allergy medicine
Zip code
Address
3-39-15 Maebashi, Gunma, Japan
TEL
027-220-7111
Homepage URL
shinkita.s50@gmail.com
Sponsor or person
Institute
Gunma University Hospital
Institute
Department
Personal name
Funding Source
Organization
Gunma University Hospital
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 19 | 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
Date of protocol fixation
| 2016 | Year | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | 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
prospective observational study
study duration:01/Jul/2016-30/Jun/2018
Management information
Registered date
| 2016 | Year | 07 | Month | 18 | Day |
Last modified on
| 2016 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026757
