UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000014760
Receipt No. R000016933
Scientific Title Preliminary study detecting of plasma soluble PD-L1 in the patients with advanced lung cancer
Date of disclosure of the study information 2014/08/30
Last modified on 2019/03/22 (Ver. 24)

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Basic information
Public title Preliminary study detecting of plasma soluble PD-L1 in the patients with advanced lung cancer
Acronym soluble PD-L1 with advanced lung cancer
Scientific Title Preliminary study detecting of plasma soluble PD-L1 in the patients with advanced lung cancer
Scientific Title:Acronym soluble PD-L1 with advanced lung cancer
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of the present study is to elucidate whether plasma PD-L1, which leads to T-cell exhaustion, is present or not in the patients with advanced lung cancer.
Basic objectives2 Others
Basic objectives -Others none
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To detect whether soluble PD-L1 is detectable or not in the plasma of patients with advanced lung cancer (before first-line chemotherapy or day after last day of the chemotherapy)
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 Inclusion criterion of the present study is the patients who treated with chemotherapy at Komagome Hospital. Before being underwent chemotherapy, the patients examined blood sample with tube (or EDTA) contains sodium heparin of the 4mL. Then, collected blood samples (upto 32 samples) are exploratory checked for soluble PD-L1 whether it could be detectable or not at Tokyo Jikei University.
Key exclusion criteria Other than that above
Target sample size 96

Research contact person
Last name of lead principal investigator
1st name Sadamu
Middle name
Last name Honma
Organization Research Center for Medical Science, The Jikei University of Medicine
Division name Division of Oncology
Zip code 113-8677
Address NishiShinbashi 3-25-8, Minato, Tokyo
TEL 03-3433-1111
Email shonma@jike.ac.jp

Public contact
1st name of contact person
1st name Yusuke
Middle name
Last name Okuma
Organization Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Division name Department of Thoracic Oncology and Respiratory Medicine
Zip code 113-8677
Address Honkomagome 3-18-22, Bunkyo, Tokyo
TEL 03-3823-2101
Homepage URL
Email y-okuma@cick.jp

Sponsor
Institute Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Institute
Department

Funding Source
Organization Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor The Jikei University School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics committee of Tokyo Metropolitan Komagome Hospital
Address Honkomagome 3-18-22, Bunkyo, Tokyo
Tel 03-3823-2101
Email rinri@cick.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 がん・感染症センター都立駒込病院（東京）
東京慈恵会医科大学医科学研究センター（東京）

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 30 Day

Related information
URL releasing protocol http://www.lungcancerjournal.info/article/S0169-5002(16)30539-6/abstract
Publication of results Published

Result
URL related to results and publications http://www.lungcancerjournal.info/article/S0169-5002(16)30539-6/abstract
Number of participants that the trial has enrolled 96
Results 
The implication of soluble PD-L1 (sPD-L1) in lung cancer patients remains unknown. The present study demonstrated that high levels of sPD-L1 was associated with poor prognosis in advanced lung cancer. sPD-L1 may be a useful biomarker for immune checkpoint therapy.
Results date posted
2019 Year 03 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2017 Year 02 Month 02 Day
Baseline Characteristics 
Advanced NSCLC patients who were treated with chemotherapy before treatment or 3 weeks at least after administration chemotherapy are enrolled.
Participant flow 
The patients met the above criteria provide a blood sample with daily practice.
Adverse events 
None (because of the observational study)
Outcome measures 
96 patients were analyzed. 65 patients were naive to chemotherapy, and 20 had received two or more lines of chemotherapy. No correlation of the plasma sPD-L1 level with histological subtypes, adenocarcinoma genetic status, smoking history, clinical stage or laboratory data was found. However, overall survival was significantly reduced in patients with high (more than 7.32？ng/ml) compared with low (less than 7.32？ng/ml) plasma sPD-L1 levels (13.0 vs. 20.4 months, p？=？0.037). Multivariate analysis revealed that high sPD-L1 levels were significantly related to poor prognosis (hazard ratio 1.99, p？=？0.041).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2014 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 27 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2016 Year 04 Month 01 Day
Date analysis concluded
2016 Year 04 Month 01 Day

Other
Other related information none

Management information
Registered date
2014 Year 08 Month 04 Day
Last modified on
2019 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016933