UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025834 |
|---|---|
| Receipt number | R000029708 |
| Scientific Title | Study of predictive factors of adverse events and therapeutic effects of immune checkpoint inhibitors in patients with solid cancer. |
| Date of disclosure of the study information | 2017/01/24 |
| Last modified on | 2017/01/24 23:46:55 |
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Basic information
Public title
Study of predictive factors of adverse events and therapeutic effects of immune checkpoint inhibitors in patients with solid cancer.
Acronym
To Investigate Marker of adverse events and therapeutic effects of immune-checkpoint inhibitors
Scientific Title
Study of predictive factors of adverse events and therapeutic effects of immune checkpoint inhibitors in patients with solid cancer.
Scientific Title:Acronym
To Investigate Marker of adverse events and therapeutic effects of immune-checkpoint inhibitors
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 the mechanism and predictive markers of immune-related adverse events(irAE) by measuring the PD - 1 receptor occupation rate of immune-checkpoint inhibitor in peripheral blood T lymphocyte.
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
Relationship between the occupancy ratio of immune-checkpoint inhibitors to receptors on peripheral blood CD8 T-lymphocytes and adverse event occurrence in cancer patients with irAE.
Key secondary outcomes
1)Relationship between the occupancy rate of immune-checkpoint inhibitors in peripheral blood mononuclear cell subsets and adverse events, clinical effects (response rate, progression-free survival).
(2)Mononuclear cell fractionation Presence or absence of activation for each cell subtype.
(3)Relationship between occurrence of immunological adverse events and response rate and progression-free survival.
(4)In cancer patients treated with immune checkpoint inhibitors, searching for factors involved in adverse events and therapeutic effects (such as soluble PD-L1, HLA class I and II).
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) Age of more than 20 years old .
(2) Written informed consent.
Key exclusion criteria
(1) HBs antigen, HCV antibody, HIV antibody are positive.
(2) An inappropriate case judged by doctor in charge.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyuki HAMADA |
Organization
Showa University School of Medicine
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 School of Medicine
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
Department of Immuno Oncology.
Clinical Research Institute of Clinical Pharmacology and
Therapeutics.
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 | 01 | Month | 24 | 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
| 2016 | Year | 11 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 24 | 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 immune-checkpoint inhibitors at Showa University Hospital and meet to our inclusion criteria.
We obtain peripheral blood mononucear cells and plasma sample from the patients with irAE.
Measurements of plasma levels of cytokines.
To evaluate the lymphocyte activation and PD-1 receptor occupancy in peripheral blood lymphocyte subsets.
Management information
Registered date
| 2017 | Year | 01 | Month | 24 | Day |
Last modified on
| 2017 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029708
