UMIN-CTR Clinical Trial

Basic information
Public title	A biomarker study of soluble immune markers in stage II-IIIA non-small cell lung cancer (WJOG12319LTR)
Acronym	A soluble immune biomarker study in resectable non-small cell lung cancer (WJOG12319LTR)
Scientific Title	A biomarker study of soluble immune markers in stage II-IIIA non-small cell lung cancer (WJOG12319LTR)
Scientific Title:Acronym	A soluble immune biomarker study in resectable non-small cell lung cancer (WJOG12319LTR)
Region	Japan

Condition
Condition	Resectable stage II-IIIA 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 evaluate the soluble immune markers (soluble PD-L1, soluble PD-1, soluble CTLA-4) as biomarkers in resectable NSCLC patients.
Basic objectives2	Others
Basic objectives -Others	Evaluation of biomarkers
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Association of soluble immune markers, including soluble PD-L1, soluble PD-1, soluble CTLA-4, and relapse-free survival / overall survival in resectable stage II-IIIA NSCLC
Key secondary outcomes	Association of soluble immune markers, including soluble PD-L1, soluble PD-1, soluble CTLA-4, and clinical background / characteristics

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	75 years-old >
Gender	Male and Female
Key inclusion criteria	Patients enrolled in WJOG4107 study who had available plasma samples
Key exclusion criteria	None
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Hidetoshi Middle name Last name Hayashi
Organization	Kindai University, Faculty of Medicine
Division name	Department of Medical Oncology
Zip code	589-8511
Address	377-2, Ohno-higashi, Osaka-Sayama, 589-8511, Japan
TEL	072-366-0221
Email	hidet31@med.kindai.ac.jp

Public contact
Name of contact person	1st name Shinichiro Middle name Last name Nakamura
Organization	West Japan Oncology Group
Division name	WJOG datacenter
Zip code	556-0016
Address	Namba Plaza Bldg. 304-1-5-7, Motomachi Naniwa-ku, Osaka, JAPAN
TEL	06-6633-7400
Homepage URL
Email	datacenter@wjog.jp

Sponsor
Institute	West Japan Oncology Group
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kindai University Hospital
Address	377-2 Ohnohigashi, Osaka-Sayama City, Osaka
Tel	072-366-0221
Email	tanizaki_j@med.kindai.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	2019 Year 08 Month 26 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	152
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	2019 Year 08 Month 23 Day
Date of IRB	2019 Year 09 Month 09 Day
Anticipated trial start date	2019 Year 09 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A retrospective study to evaluate the association of soluble PD-L1, soluble PD-1, soluble CTLA-4 and clinical background/characteristics and prognosis in reseactable stageII-IIIA NSCLC

Management information
Registered date	2019 Year 08 Month 19 Day
Last modified on	2022 Year 08 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042994