UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020823 |
|---|---|
| Receipt number | R000024033 |
| Scientific Title | Prospective observational study of biomarkers to predict efficacy after Nivolumab in patients with previously treated advanced non-small cell lung cancer. |
| Date of disclosure of the study information | 2016/02/01 |
| Last modified on | 2016/09/05 12:06:00 |
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Basic information
Public title
Prospective observational study of biomarkers to predict efficacy after Nivolumab in patients with previously treated advanced non-small cell lung cancer.
Acronym
Exploration of biomarker after Nivolumab in lung cancer
Scientific Title
Prospective observational study of biomarkers to predict efficacy after Nivolumab in patients with previously treated advanced non-small cell lung cancer.
Scientific Title:Acronym
Exploration of biomarker after Nivolumab in lung cancer
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Nivolumab is active for treatment of previously treated NSCLC. However, there have been no established biomarker to predict the efficcy and outcome after administration of Nivolumab. In this study, we explored the promising markers as a prediction of Nivolumab using blood samples.
Basic objectives2
Others
Basic objectives -Others
We analyze the expression of PD-L1 within circulating cancer cells by CTC methods.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To explore the pretictive biomarkers after and before Nivolumab using blood samples.
Key secondary outcomes
Potential of monitoring Nivolumab by any biomarkers
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
Candidate for administration of nivolumab
with written informed consent
Key exclusion criteria
Judgement as exclusion by chief mdical physians
having auto-immune diseases
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyoichi Kaira |
Organization
Gunma University
Division name
Oncology Clinical Development
Zip code
Address
showa-machi. Maebashi, Gunma
TEL
027-220-8136
kkaira1970@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kyoichi Kaira |
Organization
Gunma University
Division name
Oncology Clinical Development
Zip code
Address
showa-machi. Maebashi, Gunma
TEL
027-220-8136
Homepage URL
kkaira1970@yahoo.co.jp
Sponsor or person
Institute
Gunma University
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
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 | 02 | Month | 01 | 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
| 2016 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | 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
Study design; Cohort study
Registration: Feb. 2016 to Jan. 2019, compatible with inclusion criteria
Using blood sample, any biomarkers before and after nivolumab administration and measured. In the first 5 patients, several points after 1,2,3,4w, 3m,6m and PD are assessed to find an appropriate point after nivolumab. Where we idenfy an optimal point, two points before and afternivolumab are evaluated. Any blood samples are used to do CTC and exosome analysis, examining immune enviromental biomarkers such as PD-L1, PD-L2, CD4 and CD8. We explored the relationship between the efficacy of nivolumab and the expression level of these markers.
Management information
Registered date
| 2016 | Year | 02 | Month | 01 | Day |
Last modified on
| 2016 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024033
| 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 |
