UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024414 |
|---|---|
| Receipt number | R000028098 |
| Scientific Title | An exploratory biomarker study of immunecheckpoint inhibitors using tumor tissue and peripheral blood |
| Date of disclosure of the study information | 2016/10/14 |
| Last modified on | 2021/10/18 17:38:51 |
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Basic information
Public title
An exploratory biomarker study of immunecheckpoint inhibitors using tumor tissue and peripheral blood
Acronym
A biomarker study of immunecheckpoint inhibitors
Scientific Title
An exploratory biomarker study of immunecheckpoint inhibitors using tumor tissue and peripheral blood
Scientific Title:Acronym
A biomarker study of immunecheckpoint inhibitors
Region
| Japan |
Condition
Condition
lung cancer, and melanoma
Classification by specialty
| Pneumology | Hematology and clinical oncology | Dermatology |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore the predictive utility of tissue and blood biomarkers in patients with lung cancer or melanoma who are treated with immune checkpoint inhibitors
Basic objectives2
Others
Basic objectives -Others
See above
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To examine the utility of tissue and blood biomarkers before and during treatment.
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. Patients who are diagnosed as lung cancer or melanoma, and can be provide tissue and blood samples with this study.
2. Patients who will be treated with immunecheckpoint inhibitors
3. To obtain written informed consent from patients
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Yamamoto |
Organization
Wakayama Medical University
Division name
Respiratory Medicine and Medical Oncology
Zip code
641-8509
Address
811-1, Kimiidera, Wakayama-city
TEL
073-441-0619
nbyamamo@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki and Yasuhiro |
| Middle name | |
| Last name | Akamatsu and Koh |
Organization
Wakayama Medical University
Division name
Respiratory Medicine and Medical Oncology
Zip code
641-8509
Address
811-1, Kimiidera, Wakayama-city
TEL
073-441-0619
Homepage URL
h-akamat@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama Medical University IRB
Address
811-1, Kimiidera, Wakayama-city
Tel
073-447-2300
wa-rinri@wakayama-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
| 2016 | Year | 10 | Month | 14 | 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
120
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Currently analyzing.
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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 09 | Month | 30 | Day |
Other
Other related information
None
Management information
Registered date
| 2016 | Year | 10 | Month | 14 | Day |
Last modified on
| 2021 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028098
