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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024414
Receipt No. R000028098
Scientific Title An exploratory biomarker study of immunecheckpoint inhibitors using tumor tissue and peripheral blood
Date of disclosure of the study information 2016/10/14
Last modified on 2017/10/15

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Basic information
Public title An exploratory biomarker study of immunecheckpoint inhibitors using tumor tissue and peripheral blood
Acronym A biomarker study of immunecheckpoint inhibitors
Scientific Title An exploratory biomarker study of immunecheckpoint inhibitors using tumor tissue and peripheral blood
Scientific Title:Acronym A biomarker study of immunecheckpoint inhibitors
Region
Japan

Condition
Condition lung cancer, and melanoma
Classification by specialty
Pneumology Hematology and clinical oncology Dermatology
Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To explore the predictive utility of tissue and blood biomarkers in patients with lung cancer or melanoma who are treated with immune checkpoint inhibitors
Basic objectives2 Others
Basic objectives -Others See above
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To examine the utility of tissue and blood biomarkers before and during treatment.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients who are diagnosed as lung cancer or melanoma, and can be provide tissue and blood samples with this study.
2. Patients who will be treated with immunecheckpoint inhibitors
3. To obtain written informed consent from patients
Key exclusion criteria None
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Yamamoto
Organization Wakayama Medical University
Division name Respiratory Medicine and Medical Oncology
Zip code
Address 811-1, Kimiidera, Wakayama-city
TEL 073-441-0619
Email nbyamamo@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Akamatsu, and Yasuhiro Koh
Organization Wakayama Medical University
Division name Respiratory Medicine and Medical Oncology
Zip code
Address 811-1, Kimiidera, Wakayama-city
TEL 073-441-0619
Homepage URL
Email h-akamat@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
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 10 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 Open public recruiting
Date of protocol fixation
2016 Year 01 Month 13 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2016 Year 10 Month 14 Day
Last modified on
2017 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028098

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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