UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029994 |
|---|---|
| Receipt number | R000034253 |
| Scientific Title | Prospective observational study to evaluate the efficacy and safety of PD-1/PD-L1 antibody by PK/PD/PGx analysis. |
| Date of disclosure of the study information | 2017/11/16 |
| Last modified on | 2022/11/20 10:23:05 |
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Basic information
Public title
Prospective observational study to evaluate the efficacy and safety of PD-1/PD-L1 antibody by PK/PD/PGx analysis.
Acronym
NCCH-1605
Scientific Title
Prospective observational study to evaluate the efficacy and safety of PD-1/PD-L1 antibody by PK/PD/PGx analysis.
Scientific Title:Acronym
NCCH-1605
Region
| Japan |
Condition
Condition
Lung Cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Explore the predictive factors for efficacy and safety of PD-1/PD-L1 antibody by PK/PD/PGx analysis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response Rate
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older who are diagnosed as inoperable or recurrent lung cancer and scheduled to receive anti PD-1/PD-L1 antibody.
Key exclusion criteria
Not applicable
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Ohe |
Organization
National Cancer Center Hospital
Division name
Thoracic Oncology
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
yohe@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | ygoto@ncc.go.jp |
Organization
National Cancer Center Hospital
Division name
Thoracic Oncology
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
ygoto@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Address
Tel
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
| 2017 | Year | 11 | Month | 16 | 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
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 11 | Month | 16 | Day |
Last modified on
| 2022 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034253
