UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042005 |
|---|---|
| Receipt number | R000047940 |
| Scientific Title | Comprehensive anti-tumor immunity evaluation system for thoracic malignancies using peripheral blood mononuclear cell |
| Date of disclosure of the study information | 2020/10/04 |
| Last modified on | 2020/10/04 23:40:49 |
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Basic information
Public title
Comprehensive anti-tumor immunity evaluation system for thoracic malignancies using peripheral blood mononuclear cell
Acronym
Comprehensive anti-tumor immunity evaluation system for thoracic malignancies using peripheral blood mononuclear cell
Scientific Title
Comprehensive anti-tumor immunity evaluation system for thoracic malignancies using peripheral blood mononuclear cell
Scientific Title:Acronym
Comprehensive anti-tumor immunity evaluation system for thoracic malignancies using peripheral blood mononuclear cell
Region
| Japan |
Condition
Condition
thoracic malignancies
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Develop biomarkers to predict the efficacy and prognosis of immune checkpoint inhibitors
Basic objectives2
Others
Basic objectives -Others
Develop biomarkers for simple and versatile immune checkpoint inhibitors using peripheral blood
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
results of PBMC analysis
Key secondary outcomes
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
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with thoracic malignancies (including clinically diagnosed cases)
2. Patients receiving anti-cancer drug treatment or radiation therapy
3. Over 20 years old at the time of consent
4. Patients with written consent to this study
Key exclusion criteria
1. Patients who do not agree to this study in writing
2. Patients judged by the physician to be inappropriate for participation in this study
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Ou |
| Middle name | |
| Last name | Yamaguchi |
Organization
Saitama Medical University International Medical Center
Division name
respiratory medicine
Zip code
350-1298
Address
1397-1, Yamane, Hidaka City, Japan
TEL
042-984-4111
ouyamagu@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Ou |
| Middle name | |
| Last name | Yamaguchi |
Organization
Saitama Medical University International Medical Center
Division name
respiratory medicine
Zip code
350-1298
Address
1397-1, Yamane, Hidaka City, Japan
TEL
042-984-4111
Homepage URL
ouyamagu@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University International Medical Center
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
Saitama Medical University International Medical Center
Address
1397-1, Yamane, Hidaka City, Japan
Tel
042-984-4523
chikens@saitama-med.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
| 2020 | Year | 10 | Month | 04 | 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
| 2020 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In addition to PBMC blood sampling, serum, whole blood, and tissues are stored.
Management information
Registered date
| 2020 | Year | 10 | Month | 04 | Day |
Last modified on
| 2020 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047940
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
