UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023873
Receipt No. 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 2017/07/11

* 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
Email 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
Email suzukih@opho.jp

Sponsor
Institute Respiratory Medicine, Allergy and Rheu matic Diseases Osaka University Graduate School of Medicine
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2016 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 31 Day
Last modified on
2017 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027498

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.