UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029994
Receipt No. 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 2017/11/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email ygoto@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

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
Email

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 Enrolling by invitation
Date of protocol fixation
2016 Year 10 Month 24 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 04 Day
Last follow-up date
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
2017 Year 11 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034253

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.