UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014760 |
|---|---|
| Receipt number | 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 11:43:40 |
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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
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
shonma@jike.ac.jp
Public contact
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
y-okuma@cick.jp
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016933
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