UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Studies on the frequency of PDL-1 positive peripheral mononuclear cells and blood level of soluble PDL-1 in pancreatic cancer patients treated with dendritic cell therapy
Title of the study (Brief title)	Studies on the frequency of PDL-1 positive peripheral mononuclear cells and blood level of soluble PDL-1 in pancreatic cancer patients treated with dendritic cell therapy
Region	Japan

Condition
Condition	pancreatic cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Tumor-induced immuno-suppression might be involved in one of the causes of poor prognosis of pancreatic cancer. Programmed cell death-1 (PD-1)/programmed cell death ligand-1 (PDL-1) interaction is a pivotal molecular mechanism of the suppression of antitumor immunity. We found that the frequency of PDL-1 positive peripheral blood mononuclear cells (PBMCs) and blood level of soluble PDL-1 (sPDL-1) were high in pancreatic acncer patients. The association of these two factors and prognosis of the pancreatic cancer patients treated with the dendritic cell therapy will be investigated.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Frequency of PDL-1 positive peripheral mononuclear cells
Key secondary outcomes	Concentration of blood soluble PDL-1

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	Pancreatic cancer patients treated with the dendritic cell therapy in Kashiwa Hospital of Jikei University School of Medicine
Key exclusion criteria	Pancreatic cancer patients not applicable to the dendritic cell therapy
Target sample size	10

Research contact person
Name of lead principal investigator	Sadamu Homma
Organization	Jikei University School of Medicine
Division name	Division of Oncology
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	Sadamu Homma
Organization	Jikei University School of Medicine
Division name	Division of Oncology
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	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2018 Year 06 Month 30 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 06 Month 18 Day
Anticipated trial start date	2015 Year 06 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	The frequency of PDL-1 positive PBMCs of the pancreatic cancer patients treated with the dendritic cell therapy will be determined by FACS analysis. Blood level of sPDL-1 will be determined by ELISA assay.

Management information
Registered date	2017 Year 10 Month 02 Day
Last modified on	2017 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033573