UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023873 |
|---|---|
| Receipt number | R000027498 |
| Scientific Title | A study of evaluation to the predictive biomarker of Nivolumab in peripheral blood and pleural effusion. |
| Date of disclosure of the study information | 2016/08/31 |
| Last modified on | 2022/03/07 08:27:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study of evaluation to the predictive biomarker of Nivolumab in peripheral blood and pleural effusion.
Acronym
A biomarker study of of Nivolumab in blood and pleural effusion.
Scientific Title
A study of evaluation to the predictive biomarker of Nivolumab in peripheral blood and pleural effusion.
Scientific Title:Acronym
A biomarker study of of Nivolumab in blood and pleural effusion.
Region
| Japan |
Condition
Condition
previously treated patients with advanced non-small-cell lung cancer
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal predictive biomarker for nivolmab
Basic objectives2
Others
Basic objectives -Others
response rate, progression free survival, overall survival
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
We study biomarkers in peripheral blood and pleural effusion between before and 2-4 week after Nivolumab treatment start.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Collecting pleural effusion and blood before and after Nivolumab treatment
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)Histologically or cytologically comfarmed non-small-cell lung cancer
2)Stage VI or recurrent diseases (without any indications for operation and radiotherapy) with pleural effusion that can be taken
3)Have measuarable lesion in lung by using the RECIST ver1.1 (Response Evaluation Criteria In Solid Tumors) criteria.
4)Twenty or more years old at tnetime of imformed consent
5)Eastern Coopperative Oncology Group Perfoemance Status (ECOG PS)0-1
6)Have adequate organ function within 14 days before entry
7)Estimate life expectancy of at least 12 weeks
8)Have signed an informed consent document
Key exclusion criteria
1)With interstitial pneumonia or pulmonary fibrosis on a chest X-ray
2)Clinically significant drug allergy
3)Presencee of other active malignancy
4)With pericardial effusion, pleural effusion and ascites in need of treatment of drainage
5)Positive serum HBs antigen
6)With severe infection, cardiac diseases, diabates, hypertention, other severe complication
7)Patients received palliative radiotherapy for brain metastases and bone metastases, except for the primary lesion within 2weeks.
8)Pregnancy or lactating patients
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Kumanogoh |
Organization
Osaka University Medical School
Division name
Respiratory Medicine, Allergy and Rheu matic Diseases Osaka University Gradu ate School of Medicine
Zip code
Address
2-2 Yamada-oka, Suita, Osaka
TEL
06-6879-3831
kumanogo@imed3.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidekazu Suzuki |
Organization
Osaka Habikino Medical Center
Division name
Department of Thoracic oncology
Zip code
Address
3-7-1 Habikino, Habikino-shi, Osaka
TEL
+81-72-957-2121
Homepage URL
suzukih@opho.jp
Sponsor or person
Institute
Respiratory Medicine, Allergy and Rheu matic Diseases Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD.
Bristol-Myers Squibb.
Organization
Division
Category of Funding Organization
Profit organization
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 | 08 | Month | 31 | 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
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 31 | Day |
Last modified on
| 2022 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027498
