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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023822
Receipt No. R000027442
Scientific Title Prospective study of evaluation to the predictive biomarker of Nivolumab by tumor tissue specimen and neighboring bronchoaveolar lavage fluid (BALF) and Blood
Date of disclosure of the study information 2016/08/30
Last modified on 2019/01/27

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Basic information
Public title Prospective study of evaluation to the predictive biomarker of Nivolumab by tumor tissue specimen and neighboring bronchoaveolar lavage fluid (BALF) and Blood
Acronym Evaluation to the predictive biomarker of Nivolumab by Tumor tissue, BALF, and Blood
Scientific Title Prospective study of evaluation to the predictive biomarker of Nivolumab by tumor tissue specimen and neighboring bronchoaveolar lavage fluid (BALF) and Blood
Scientific Title:Acronym Evaluation to the predictive biomarker of Nivolumab by Tumor tissue, BALF, and Blood
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 YES

Objectives
Narrative objectives1 We will reveal predictive biomarker for nivolmab
Basic objectives2 Others
Basic objectives -Others Evaluate the tumor tissue, BALF, and blood collection between before nivolumab treatment and at the disease progression or appearing the new lesion in lung
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We will reveal predictive biomarker for nivolmab by evaluate the tumor tissue, BALF, and blood collection.
Key secondary outcomes Progression free Survival, Overall Survival, Response Rate, Disease Control Rate, safety

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
Maneuver
Interventions/Control_1 Performe tumor biopsy, BAL, and blood collection before the Nivolumab treatment.
Performe tumor biopsy, BAL, and blood collection at disease progression and appearing new lesion in the lung during 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 documented non-small-cell lung cancer
(2)Stage VI or recurrent diseases without any indications for operation and radiotherapy
(3)Have measuarable lesion in lung by using the RECIST ver1.1 (Response Evaluation Criteria In Solid Tumors) criteria and can performe tumor biopsy by bronchoscopy
(4)Must be 20 or more years old at tne time of consent
(5)Have Eastern Coopperative Oncology Group Perfoemance Status (ECOG PS) 0-1
(6)Have adequate organ function within two weeks before study 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
(9)The case that be judged as the inappropriate object of the this examination
Target sample size 20

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 Rheumatic Diseases Osaka University Graduate School of Medicine
Zip code
Address 2-2 Yamada-oka, Suita, Osaka
TEL +81-(0)6-6879-3830
Email kumanogo@imed3.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motohiro Tamiya
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name Thoracic Oncology
Zip code
Address 1-3-3 Nakamichi, Higashinari-ku, Osaka, Osaka
TEL +81-(0)6-6972-1181
Homepage URL
Email moto19781205@yahoo.co.jp

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

Funding Source
Organization ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Bristol-Myers Squibb

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 大阪大学(大阪府)
大阪府立呼吸器・アレルギー医療センター(大阪府)
大阪府立成人病センター(大阪府)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 30 Day

Related information
URL releasing protocol
Publication of results Partially published

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 19 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 29 Day
Last modified on
2019 Year 01 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027442

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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