UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024051
Receipt number R000027695
Scientific Title Prospective study of predictive markers in nivolumab immunotherapy
Date of disclosure of the study information 2016/09/14
Last modified on 2016/09/14 13:09:59

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Basic information

Public title

Prospective study of predictive markers in nivolumab immunotherapy

Acronym

Prospective study of predictive markers in nivolumab immunotherapy

Scientific Title

Prospective study of predictive markers in nivolumab immunotherapy

Scientific Title:Acronym

Prospective study of predictive markers in nivolumab immunotherapy

Region

Japan


Condition

Condition

lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Usefulness of circulating immune complexes as a predictive marker for nivolumab therapy agianst lung cancer patients will be determined.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relationship between efficacy of nivolumab and immune complexes

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

lung cancer patients
over 20 years old
treated with Nivolumab
agreed to this study by a document

Key exclusion criteria

ruled unfit to this study by attending physician

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takaya Ikeda

Organization

Nagasaki University Hospital

Division name

Second department of internal medicine

Zip code


Address

1-7-1 Sakamoto Nagasaki Japan

TEL

095-819-7273

Email

ikedat@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takaya Ikeda

Organization

Nagasaki University Hospital

Division name

Second Department of Internal Medicine

Zip code


Address

1-7-1 Sakamoto Nagasaki Japan

TEL

095-819-7273

Homepage URL


Email

ikedat@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Other

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

長崎大学病院


Other administrative information

Date of disclosure of the study information

2016 Year 09 Month 14 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

2016 Year 08 Month 22 Day

Date of IRB


Anticipated trial start date

2016 Year 09 Month 02 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Nothing in particular


Management information

Registered date

2016 Year 09 Month 14 Day

Last modified on

2016 Year 09 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027695


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name