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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Main results already published |
Unique ID issued by UMIN | UMIN000021694 |
Receipt No. | R000024740 |
Scientific Title | Single-institutional observational surveillance of nivolumab for previously treated with non-small cell lung cancer |
Date of disclosure of the study information | 2016/04/01 |
Last modified on | 2019/03/22 |
Basic information | ||
Public title | Single-institutional observational surveillance of nivolumab for previously treated with non-small cell lung cancer | |
Acronym | observational study of nivolumab | |
Scientific Title | Single-institutional observational surveillance of nivolumab for previously treated with non-small cell lung cancer | |
Scientific Title:Acronym | observational study of nivolumab | |
Region |
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Condition | ||
Condition | non-small cell lung cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate the predictive factor response with clinical characteristics |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | response rate |
Key secondary outcomes | progression-free survival; overall survival; safety; predictive factor of prognosis and safety |
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 | |
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Interventions/Control_7 | |
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Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | All patients treated with nivolumab for previously treated with NSCLC from 2016 | |||
Key exclusion criteria | inadequate patients for nivolumab treatment | |||
Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Tokyo Metropolitan Komagome Hospital | ||||||
Division name | Department of Thoracic Oncology | ||||||
Zip code | 113-8677 | ||||||
Address | 3-18-22, Honkomagome, Bunkyo, Tokyo, JAPAN | ||||||
TEL | 03-3823-2101 | ||||||
y-okuma@cick.jp |
Public contact | |||||||
Name of contact person |
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Organization | Tokyo Metropolitan Komagome Hospital | ||||||
Division name | Department of Thoracic Oncology | ||||||
Zip code | 113-8677 | ||||||
Address | 3-18-22, Honkomagome, Bunkyo, Tokyo, JAPAN | ||||||
TEL | 03-3823-2101 | ||||||
Homepage URL | |||||||
y-okuma@cick.jp |
Sponsor | |
Institute | Tokyo Metropolitan Komagome Hospital |
Institute | |
Department |
Funding Source | |
Organization | Tokyo Metropolitan Komagome 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 | Ethics committee of Tokyo Metropolitan Komagome Hospital |
Address | 3-28-22, Honkomagome, Bunkyo, Tokyo |
Tel | 03-3823-2101 |
rinri@cick.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 |
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Related information | |
URL releasing protocol | https://www.ncbi.nlm.nih.gov/pubmed/30655989 |
Publication of results | Published |
Result | |||||||
URL related to results and publications | https://www.ncbi.nlm.nih.gov/pubmed/30655989 | ||||||
Number of participants that the trial has enrolled | 67 | ||||||
Results | The patients who were treated with nivolumab as the standard of care were enrolled. | ||||||
Results date posted |
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Results Delayed | |||||||
Results Delay Reason | |||||||
Date of the first journal publication of results | |||||||
Baseline Characteristics | The patients who were treated with nivolumab as the standard of care were enrolled. | ||||||
Participant flow | The patients who were treated with nivolumab as the standard of care were enrolled. | ||||||
Adverse events | we have published in the articles | ||||||
Outcome measures | we have published in the articles | ||||||
Plan to share IPD | |||||||
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Main results already published | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Case control study. We will assess clinical demographic, diagnosis, histological subtypes, treatment of nivolumab, clinical outcome (response, time-to-event), or laboratory data. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024740 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |