UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028474 |
|---|---|
| Receipt number | R000032594 |
| Scientific Title | An exploratory prospective study of the biomarkers of the immune-related adverse events (irAE) and the mechanisms of irAE in solid cancer patients treated with Pembrolizumab. |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2017/08/01 03:39:35 |
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Basic information
Public title
An exploratory prospective study of the biomarkers of the immune-related adverse events (irAE) and the mechanisms of irAE in solid cancer patients treated with Pembrolizumab.
Acronym
An exploratory study of immune-related adverse events in patients treated with Pembrolizumab.
Scientific Title
An exploratory prospective study of the biomarkers of the immune-related adverse events (irAE) and the mechanisms of irAE in solid cancer patients treated with Pembrolizumab.
Scientific Title:Acronym
An exploratory study of immune-related adverse events in patients treated with Pembrolizumab.
Region
| Japan |
Condition
Condition
solid cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate relation between occupation rate of PD-1 receptor on Tcells and clinical effect and immune-related adverse events.
Basic objectives2
Others
Basic objectives -Others
Search for biomarkers on immune-related adverse events and therapeutic effects.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relation between occupation rate of PD-1 receptor on Tcells and clinical effect and occurrence of immune-related adverse events.
Key secondary outcomes
The elationship between peripheral blood T cell subsets and irAE, response rate, 6-month progression free survival rate, and 1 year survival rate.
The relationship between microflora of the gastrointestinal tract, oral cavity, and blood and irAE, response rate, 6-month progression free survival rate, and 1 year survival rate.
The relationship between PD-L1 expression of tumor tissue and predictions of therapeutic effect (response rate, 6-month progression free survival rate, and 1 year survival rate) and irAE.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) ECOG performance status (PS) of 0 to 2.
(2) Age of more than 20 years old.
(3) Written informed consent.
Key exclusion criteria
(1) HBs antigen, HCV antibody and HIV antibody is positive.
(2) An inappropriate case judged by doctor in charge.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Hamada |
Organization
Showa University
Division name
Department of Internal Medicine,Division of Medical Oncology
Zip code
Address
1-5-8, hatanodai, shinagawa-ku, Tokyo 142-8666, JAPAN
TEL
03-3784-8402
hamadakaz@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Hamada |
Organization
Showa University
Division name
Department of Internal Medicine,Division of Medical Oncology
Zip code
Address
1-5-8, hatanodai, shinagawa-ku, Tokyo 142-8666, JAPAN
TEL
03-3784-8402
Homepage URL
hamadakaz@med.showa-u.ac.jp
Sponsor or person
Institute
Department of Internal Medicine, Division of Medical Oncology, Showa University School of Medicine.
Institute
Department
Personal name
Funding Source
Organization
Department of Internal Medicine, Division of Medical Oncology, Showa University School of Medicine.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Clinial Research Institute of Clinical Pharmacology and Therapeutics, Showa University.
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
昭和大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
An observational study of solid cancer Patients who are being treated with Anticancer drug at Showa University Hospital and meet to our inclusion criteria.
We will obtain peripheral blood mononucear cells and plasma sample from the patients.
We are going to measure plasma levels of cytokines and chemokines.
We are going to measure lymphocyte subset activation and PD - 1 receptor occupation rate of Pembrolizumab on peripheral blood T lymphocyte.
Management information
Registered date
| 2017 | Year | 08 | Month | 01 | Day |
Last modified on
| 2017 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032594
