UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034312 |
|---|---|
| Receipt number | R000039118 |
| Scientific Title | Observation of changes in comprehensive immune pathology in chemotherapy including Nivolumab for patients with refractory malignant pleural mesothelioma |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2020/12/26 12:06:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Observation of changes in comprehensive immune pathology in chemotherapy including Nivolumab for patients with refractory malignant pleural mesothelioma
Acronym
Observation of changes in comprehensive immune pathology in chemotherapy including Nivolumab for patients with refractory malignant pleural mesothelioma
Scientific Title
Observation of changes in comprehensive immune pathology in chemotherapy including Nivolumab for patients with refractory malignant pleural mesothelioma
Scientific Title:Acronym
Observation of changes in comprehensive immune pathology in chemotherapy including Nivolumab for patients with refractory malignant pleural mesothelioma
Region
| Japan | Asia(except Japan) |
Condition
Condition
Malignant pleural mesothelioma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Prediction of the effect of Nivolumab on malignant pleural mesothelioma Search for biomarkers
Basic objectives2
Others
Basic objectives -Others
Observation of comprehensive immune pathology before and after chemotherapy including Nivolbam is performed on exacerbating malignant pleural mesothelioma with progression and recurrence with exacerbation and at the time of judgment of efficacy in continuous treatment (or when a disease state changes) By doing so, we aim to search for biomarkers for predicting the effects of opigo in malignant pleural mesothelioma.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comprehensive station immune dynamics using peripheral blood before Bivolbam administration, 5 to 7 days after administration and after about 3 months
Key secondary outcomes
Search biomarkers after analysis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Malignant pleural mesothelioma of unresectable progression and recurrence exacerbated after cancer chemotherapy
Interventions/Control_2
Elderly subjects with non-tumor types (including mesothelioma), non-asbestos exposure and nonimmune diseases almost agreeing with age
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Malignant pleural mesothelioma of unresectable progression and recurrence exacerbated after cancer chemotherapy
Key exclusion criteria
Initial and resectable malignant pleural mesothelioma
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasumitsu |
| Middle name | |
| Last name | Nishimura |
Organization
Kawasaki Medical School
Division name
Department of Hygiene
Zip code
701-0192
Address
577 Mastushima, Kurashiki, Okayama, Japan
TEL
08063084002
yas@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Yasumitsu |
| Middle name | |
| Last name | Nishimura |
Organization
Kawasaki Medical School
Division name
Department of Hygiene
Zip code
7010192
Address
577 Mastushima, Kurashiki, Okayama, Japan
TEL
086-462-1111
Homepage URL
yas@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Health labor occupational injury disease clinical research project subsidy
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kawasaki Medical School
Name of secondary funder(s)
Faculty research expenses, project research expenses
IRB Contact (For public release)
Organization
Kawasaki Medical School Ethics Committee
Address
577 Matsushima
Tel
08063084002
kmsrec@med.kawasaki-m.ac.jp
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 | 12 | 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
| 2018 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 28 | Day |
Last modified on
| 2020 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039118
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
