UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029377
Receipt number R000033573
Scientific 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
Date of disclosure of the study information 2018/06/30
Last modified on 2017/10/02 12:31:52

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Basic information

Public 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

Acronym

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

Scientific 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

Scientific Title:Acronym

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

1st name
Middle name
Last name Sadamu Homma

Organization

Jikei University School of Medicine

Division name

Division of Oncology

Zip code


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
Middle name
Last name Sadamu Homma

Organization

Jikei University School of Medicine

Division name

Division of Oncology

Zip code


Address

3-25-8 Nishi-shimbashi Minato-ku Tokyo 105-8461 Japan

TEL

03-3433-1111

Homepage URL


Email

sahya@jikei.ac.jp


Sponsor or person

Institute

Jikei University School of Medicine

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2015 Year 06 Month 18 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033573


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name