UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039609 |
|---|---|
| Receipt number | R000045171 |
| Scientific Title | Biomarker study using exosomes to predict the effect of immune checkpoint inhibitors on primary lung cancer |
| Date of disclosure of the study information | 2020/02/26 |
| Last modified on | 2020/02/26 17:41:00 |
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Basic information
Public title
Biomarker study using exosomes to predict the effect of immune checkpoint inhibitors on primary lung cancer
Acronym
Biomarker study using exosomes to predict the effect of immune checkpoint inhibitors
Scientific Title
Biomarker study using exosomes to predict the effect of immune checkpoint inhibitors on primary lung cancer
Scientific Title:Acronym
Biomarker study using exosomes to predict the effect of immune checkpoint inhibitors
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify biomarker for predicting the effects and the adverse events of immune checkpoint inhibitors on primary lung cancer, using exosomes in plasma which are considered to be released from cancer cells and immune cells
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Biomarker for predicting the effects and the adverse events of immune checkpoint inhibitors
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Pathologically diagnosed with primary lung cancer
2)Scheduled to start treatment with immune checkpoint inhibitors (with or without concomitant use with cytotoxic chemotherapy)
3)Provided informed consent
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takehito |
| Middle name | |
| Last name | Shukuya |
Organization
Juntendo University
Division name
Respiratory Medicine
Zip code
113-8431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL
03-5802-1063
tshukuya@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Keita |
| Middle name | |
| Last name | Miura |
Organization
Juntendo University
Division name
Respiratory Medicine
Zip code
113-8431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL
03-5802-1063
Homepage URL
k-miura@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
kenkyu5858@juntendo.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 | 02 | Month | 26 | 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 | 01 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 02 | Month | 26 | Day |
Last modified on
| 2020 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045171
