UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027092 |
|---|---|
| Receipt number | R000030878 |
| Scientific Title | Comprehensive analysis to identify transcriptomic signatures that positively or negatively correlate with clinical outcome of nivolumab monotherapy in patients with non-small cell lung carcinoma |
| Date of disclosure of the study information | 2017/04/21 |
| Last modified on | 2018/10/25 08:28:02 |
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Basic information
Public title
Comprehensive analysis to identify transcriptomic signatures that positively or negatively correlate with clinical outcome of nivolumab monotherapy in patients with non-small cell lung carcinoma
Acronym
CTSN study
Scientific Title
Comprehensive analysis to identify transcriptomic signatures that positively or negatively correlate with clinical outcome of nivolumab monotherapy in patients with non-small cell lung carcinoma
Scientific Title:Acronym
CTSN study
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Medicine in general | Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To identify and validate transcriptomic signatures as robust predictive biomarkers for nivolumab monotherapy in patients with NSCLC
Basic objectives2
Others
Basic objectives -Others
Biomarker screening
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Identification of transcriptomic signatures that positively or negatively correlate with clinical outcome of nivolumab monotherapy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Subjects with histologically or cytologically-diagnosed NSCLC.
2) Subjects who are judged suitable for nivolumab monotherapy by investigators.
3) Recent fresh frozen tumor samples must be available for biomarker evaluation.
Key exclusion criteria
1) Subjects with a condition requiring systemic treatment with either systemic corticosteroids or other immunosuppressive medications within 14 days of first nivolumab administration.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunichi Sugawara |
Organization
Sendai Kosei Hospital
Division name
Respiratory medicine
Zip code
Address
4-15, Hirosemachi, Aoba-ku, Sendai-shi, Miyagai-ken, Japan
TEL
81-22-222-6181
swara357@cat-v.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoiki Aiba |
Organization
Sendai Kosei Hospital
Division name
Respiratory medicine
Zip code
Address
4-15, Hirosemachi, Aoba-ku, Sendai-shi, Miyagai-ken, Japan
TEL
81-22-222-6181
Homepage URL
tomowithkk@gmail.com
Sponsor or person
Institute
Sendai Kosei Hospital
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co., Ltd.
Bristol-Myers Squibb Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Division of Health Medical Computational Science, Health Intelligence Center, The Institute of Medical Science, The University of Tokyo
Laboratory of Systems Genomics, Department of Computational Biology and Medical Sciences,
Graduate School of Frontier Sciences, The University of Tokyo
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
仙台厚生病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2017 | Year | 04 | Month | 21 | Day |
Last modified on
| 2018 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030878
| Research Plan | |
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| 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 |
