UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023524 |
|---|---|
| Receipt number | 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 11:03:42 |
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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
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
sahya@jikei.ac.jp
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027082
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