UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021600 |
|---|---|
| Receipt number | R000024910 |
| Scientific Title | A prospective observational study of immune-checkpoint inhibitor (Nivolumab) treatment in patients with non-small cell lung cancer |
| Date of disclosure of the study information | 2016/03/24 |
| Last modified on | 2019/09/26 13:23:09 |
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Basic information
Public title
A prospective observational study of immune-checkpoint inhibitor (Nivolumab) treatment in patients with non-small cell lung cancer
Acronym
A prospective observational study of Nivolumab treatment
Scientific Title
A prospective observational study of immune-checkpoint inhibitor (Nivolumab) treatment in patients with non-small cell lung cancer
Scientific Title:Acronym
A prospective observational study of Nivolumab treatment
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
Monitoring a progress of Nivolumab treatment for non-small cell lung cancer patients to evaluate the efficacy and adverse effects
Basic objectives2
Others
Basic objectives -Others
Search of biomarkers to predict the efficacy or adverse effects by Nivolumab treatment
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Monitoring a progress of Nivolumab treatment for non-small cell lung cancer patients
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)Diagnosed with non-small cell lung cancer
2)Scheduled for administration of Nivolumab
3)With written informed consent
Key exclusion criteria
None
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Jiichiro |
| Middle name | |
| Last name | Sasaki |
Organization
Kitasato University School of Medicine
Division name
Research and Development Center for New Medical Frontiers
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8111
saji@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Fukui |
Organization
Kitasato University School of Medicine
Division name
Department of Respiratory Medicine
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8111
Homepage URL
tofukui@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kitasato University School of Medicine
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
the Kitasato University Medical Ethics Organization
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel
042-778-7756
rinri@med.kitasato-u.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
| 2016 | Year | 03 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
52
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
Main results already published
Date of protocol fixation
| 2016 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
50 non-small cell lung cancer patients who are treated with Nivolumab in Kitasato University Hospital between March 2016 and February 2018
Management information
Registered date
| 2016 | Year | 03 | Month | 24 | Day |
Last modified on
| 2019 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024910
