UMIN-CTR Clinical Trial

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023524
Receipt No. R000027082
Scientific Title Clinical significance of programmed cell death ligand-1 (PD-L1) expression in immune cells and soluble PD-L1 in blood of ganstrointestinal cancer patients
Date of disclosure of the study information 2016/08/08
Last modified on 2020/08/14 (Ver. 4)

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Basic information
Public title Clinical significance of programmed cell death ligand-1 (PD-L1) expression in immune cells and soluble PD-L1 in blood of ganstrointestinal cancer patients
Acronym PD-L1 expression in immune cells and soluble PD-L1 in gastrointestinal cancer patients
Scientific Title Clinical significance of programmed cell death ligand-1 (PD-L1) expression in immune cells and soluble PD-L1 in blood of ganstrointestinal cancer patients
Scientific Title:Acronym PD-L1 expression in immune cells and soluble PD-L1 in gastrointestinal cancer patients
Region
Japan

Condition
Condition Gastrointestinal Cancer
(Esophagial cancer,Gastric cancer, pancreatic cancer, liver cancer,billiary tract cancer, colorectal cancer)
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 PD-L1 expression in immune cells and soluble PD-L1 value in blood of various gastrointestinal cancer patients will be examined and their association with clinicopathological features of the diseases will be elucidated.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Correlation between PD-L1 expression in immune cells and soluble PD-L1 value.
Correlation between PD-L1 expression in immune cells or soluble PD-L1 value and PD-L1 expression in tumor tissue.
Characterstics of PD-L1 expression in immune cells or soluble PD-L1 value in each gastrointestinal cancer type.
Key secondary outcomes PD-L1 expression in immune cells or blood soluble PD-L1 value as a new biomarker for specific clinico-pathological features in gastrointestinal cancers.

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
16 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients diagnosed as esophagial cancer, gastric cancer, pancreatic cancer, billiary tract cancer, or colorectal cancer.
Patients who have agreed to provide their blood for this study.
Key exclusion criteria Patients who have not agreed to provide their blood for this study.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name SADAMU
Middle name
Last name HOMMA
Organization Jikei University School of Medicine
Division name Division of Oncology
Zip code 105-8461
Address 3-25-8 Nishi-shimbashi Minato-ku, Tokyo 105-8461 Japan
TEL 03-3433-1111
Email sahya@jikei.ac.jp

Public contact
Name of contact person
1st name Sadamu
Middle name
Last name SADAMU HOMMA
Organization Jikei University School of Medicine
Division name Division of Oncology
Zip code 105-8461
Address 3-25-8 Nishi-shimbashi Minato-ku, Tokyo 105-8461 Japan
TEL 03-3433-1111
Homepage URL
Email sahya@jikei.ac.jp

Sponsor
Institute Jikei University School of Medicine
Institute
Department

Funding Source
Organization Jikei University School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Jikei University IRB
Address 3-25-8 Nishi-shimbashi Minato-ku
Tel +81334331111
Email sahya@jikei.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 08 Month 08 Day

Related information
URL releasing protocol none
Publication of results Unpublished

Result
URL related to results and publications none
Number of participants that the trial has enrolled 85
Results 
No results to be disclosed were obtained.
Results date posted
2020 Year 08 Month 14 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Patients of gastrointestinal(GI) cancer in Jikei University Hospital
Participant flow 
Patients of GI cancer in Jikei University Hospital with agreement for the study were enrolled.
Adverse events 
none
Outcome measures 
Expression of PD-L1 in the immune cells, blood levels of sPD-L1 and the association between the above two in the patients of GI cancer.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2016 Year 05 Month 31 Day
Date of IRB
2016 Year 06 Month 14 Day
Anticipated trial start date
2016 Year 08 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information PD-L1 expression in peripheral blood mononuclear cells will be examined by FACS, and amount of soluble PD-L1 in the patient blood will be determined by ELISA.Correlation of these results and the clinico-pathological features of the patients will be analyzed.

Management information
Registered date
2016 Year 08 Month 06 Day
Last modified on
2020 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027082