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
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
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
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
