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 UMIN000020719
Receipt No. R000023906
Scientific Title Cohort study of immune-checkpoint-inhibitor antibody treatment in non-small-cell lung cancer
Date of disclosure of the study information 2016/01/24
Last modified on 2017/07/31

* 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 Cohort study of immune-checkpoint-inhibitor antibody treatment in non-small-cell lung cancer
Acronym Immune-Checkpoint-Inhibitor Cohort Study
Scientific Title Cohort study of immune-checkpoint-inhibitor antibody treatment in non-small-cell lung cancer
Scientific Title:Acronym Immune-Checkpoint-Inhibitor Cohort Study
Region
Japan

Condition
Condition non-small-cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Search for biomarkers to reveal the enabled subgroup immune-checkpoint- inhibitor
Basic objectives2 Others
Basic objectives -Others Search of biomarkers to predict the immune related adverse effect (irAE) by the immune-checkpoint-inhibitor
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes analysis of peripheral blood mononuclear cell(PBMC)
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 scheduled for administration of nivolumab
2) With written informed consent
Key exclusion criteria 1) Having psychological disorder
2) In addition, the primary doctor judging inappropriate for entry
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ou Yamaguchi
Organization Saitama Medical University International Medical Center
Division name respiratory medicine
Zip code
Address Hidaka city, Saitama
TEL 042-984-4111
Email ouyamagu@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ou Yamaguchi
Organization Saitama Medical University International Medical Center
Division name respiratory medicine
Zip code
Address Hidaka city, Saitama
TEL 042-984-4111
Homepage URL
Email ouyamagu@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University International Medical Center
Institute
Department

Funding Source
Organization Saitama medical university international medical center
Organization
Division
Category of Funding Organization Self funding
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
2016 Year 01 Month 24 Day

Related information
URL releasing protocol
Publication of results Partially published

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 01 Month 24 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 15 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prpspective cohort study of immune-checkpoint-inhibitor treatment in non-small-cell lung cancer

Management information
Registered date
2016 Year 01 Month 24 Day
Last modified on
2017 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023906

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.