UMIN-CTR Clinical Trial

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 Nobuyuki Middle name Last name Yamamoto
Organization	Wakayama Medical University
Division name	Respiratory Medicine and Medical Oncology
Zip code	641-8509
Address	811-1, Kimiidera, Wakayama-city
TEL	073-441-0619
Email	nbyamamo@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Hiroaki and Yasuhiro Middle name Last name Akamatsu and Koh
Organization	Wakayama Medical University
Division name	Respiratory Medicine and Medical Oncology
Zip code	641-8509
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	Wakayama Medical University IRB
Address	811-1, Kimiidera, Wakayama-city
Tel	073-447-2300
Email	wa-rinri@wakayama-med.ac.jp

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	120
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	Currently analyzing.
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 01 Month 13 Day
Date of IRB	2016 Year 01 Month 13 Day
Anticipated trial start date	2016 Year 01 Month 13 Day
Last follow-up date	2021 Year 01 Month 12 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2021 Year 09 Month 30 Day

Other
Other related information	None

Management information
Registered date	2016 Year 10 Month 14 Day
Last modified on	2021 Year 10 Month 18 Day

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