UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022014 |
|---|---|
| Receipt number | R000025371 |
| Scientific Title | Prediction of the effectiveness and safety of nivolumab for non-small cell lung cancer patients: a retropective cohort study |
| Date of disclosure of the study information | 2016/04/21 |
| Last modified on | 2017/04/20 15:45:54 |
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Basic information
Public title
Prediction of the effectiveness and safety of nivolumab for non-small cell lung cancer patients: a retropective cohort study
Acronym
The effectiveness and safety of nivolumab for non-small cell lung cancer patients
Scientific Title
Prediction of the effectiveness and safety of nivolumab for non-small cell lung cancer patients: a retropective cohort study
Scientific Title:Acronym
The effectiveness and safety of nivolumab for non-small cell lung cancer patients
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
To evaluate the effectiveness and safety of nivolumab for non-small cell lung cancer patients in clinical setting
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
progression free survival
Key secondary outcomes
adverse events
response rate
overall survival
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pathologically confirmed advanced non-small cell lung cancer
Treated with nivolumab after second line from 1/2016 to the date of institutional review board approval
Key exclusion criteria
none
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuki Kataoka |
Organization
Hyogo Prefectural Amagasaki General Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
Higashi-Naniwa-Cho 2-17-77, Amagasaki, Hyogo
TEL
06-6480-7000
youkitikk@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki Kataoka |
Organization
Hyogo Prefectural Amagasaki General Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
Higashi-Naniwa-Cho 2-17-77, Amagasaki, Hyogo
TEL
06-6480-7000
Homepage URL
youkitikk@gmail.com
Sponsor or person
Institute
Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General 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
兵庫県立尼崎総合医療センター（兵庫県）
地域医療機能推進機構大阪病院（大阪府）
市立伊丹病院（兵庫県）
神戸市立医療センター中央市民病院（兵庫県）
倉敷中央病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://academic.oup.com/annonc/article-abstract/3076095/Prior-radiotherapy-does-not-predict-nivolum
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 | 04 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 19 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will analyse following variables: age, gender, pathological type, stage, EGFR mutation, ALK translocation, comorbidity, CBC, chemistry.
Management information
Registered date
| 2016 | Year | 04 | Month | 21 | Day |
Last modified on
| 2017 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025371
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
