UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020719 |
|---|---|
| Receipt number | R000023906 |
| Scientific Title | Cohort study of immune-checkpoint-inhibitor antibody treatment in non-small-cell lung cancer |
| Date of disclosure of the study information | 2016/01/24 |
| Last modified on | 2017/07/31 22:09:14 |
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Basic information
Public title
Cohort study of immune-checkpoint-inhibitor antibody treatment in non-small-cell lung cancer
Acronym
Immune-Checkpoint-Inhibitor Cohort Study
Scientific Title
Cohort study of immune-checkpoint-inhibitor antibody treatment in non-small-cell lung cancer
Scientific Title:Acronym
Immune-Checkpoint-Inhibitor Cohort Study
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
Search for biomarkers to reveal the enabled subgroup immune-checkpoint- inhibitor
Basic objectives2
Others
Basic objectives -Others
Search of biomarkers to predict the immune related adverse effect (irAE) by the immune-checkpoint-inhibitor
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
analysis of peripheral blood mononuclear cell(PBMC)
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 who are scheduled for administration of nivolumab
2) With written informed consent
Key exclusion criteria
1) Having psychological disorder
2) In addition, the primary doctor judging inappropriate for entry
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ou Yamaguchi |
Organization
Saitama Medical University International Medical Center
Division name
respiratory medicine
Zip code
Address
Hidaka city, Saitama
TEL
042-984-4111
ouyamagu@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ou Yamaguchi |
Organization
Saitama Medical University International Medical Center
Division name
respiratory medicine
Zip code
Address
Hidaka city, Saitama
TEL
042-984-4111
Homepage URL
ouyamagu@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama medical university international medical center
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 | 01 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prpspective cohort study of immune-checkpoint-inhibitor treatment in non-small-cell lung cancer
Management information
Registered date
| 2016 | Year | 01 | Month | 24 | Day |
Last modified on
| 2017 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023906
| 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 |
