UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042280 |
|---|---|
| Receipt number | R000048272 |
| Scientific Title | Exploratory study on exosomal profile change during Durvalumab treatment |
| Date of disclosure of the study information | 2020/10/29 |
| Last modified on | 2021/10/30 09:11:27 |
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Basic information
Public title
Exosomal profile change during Durvalumab treatment
Acronym
Exploratory study on exosomal profile change during Durvalumab treatment
Scientific Title
Exploratory study on exosomal profile change during Durvalumab treatment
Scientific Title:Acronym
Exosomal profile change during Durvalumab treatment
Region
| Japan |
Condition
Condition
Non-Small Cell Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Time course of proteome profiles of circulating exosomes isolated from the serum of NSCLC patients treated with durvalumab.
Basic objectives2
Others
Basic objectives -Others
Clarifying specific molecules on/in exosomes regarding pneumonitis after durvalumab treatment.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time course changes of proteome profiles of circulating exosomes isolated from the serum of NSCLC patients treated with durvalumab.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients: Stage III NSCLC patients treated with CRT and subsequent durvalumab treatment. All patients provided written informed consent
Key exclusion criteria
Exclude NSCLC patients with other types of cancer.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Fujita |
| Middle name | |
| Last name | Yu |
Organization
The Jikei University School of Medicine
Division name
Department of Translational Research for Exosomes
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
yuugot@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Fujita |
| Middle name | |
| Last name | Yu |
Organization
The Jikei University School of Medicine
Division name
Department of Translational Research for Exosomes
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
yuugot@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Cancer Center Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Jikei University School of Medicine
Address
3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo
Tel
03-3433-1111
rinri@jikei.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 | 29 | 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
231
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non-interventional observational study
Management information
Registered date
| 2020 | Year | 10 | Month | 29 | Day |
Last modified on
| 2021 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048272
