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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043063
Receipt No. R000049169
Scientific Title Monitoring of TCR clonotype and diversity of CD8+PD-1+ T-cells in lung cancer patients treated with PD-1 blockade: A Biomarker Study.
Date of disclosure of the study information 2021/01/20
Last modified on 2021/01/20

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Basic information
Public title Monitoring of TCR clonotype and diversity of CD8+PD-1+ T-cells in lung cancer patients treated with PD-1 blockade: A Biomarker Study.
Acronym TCR clonotype and diversity of CD8+PD-1+ T-cells in lung cancer patients treated with PD-1 blockade
Scientific Title Monitoring of TCR clonotype and diversity of CD8+PD-1+ T-cells in lung cancer patients treated with PD-1 blockade: A Biomarker Study.
Scientific Title:Acronym TCR clonotype and diversity of CD8+PD-1+ T-cells in lung cancer patients treated with PD-1 blockade
Region
Japan

Condition
Condition Treatment naive non-small cell lung cancer patients
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the association between the efficacy of pembrolizumab and TCR clonotype on CD8+PD-1+ T-cells
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the association between the efficacy of pembrolizumab and TCR clonotype on CD8+PD-1+ T-cells
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Treatment naive Advanced NSCLC patients.
2) Treatment with pembrolizumab.
3) Written Informed consent
Key exclusion criteria 1) Patients judged as inappropriate for the study by the investigator
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Tatsuya
Middle name
Last name Yoshida
Organization National Cancer Center Hospital
Division name Department of thoracic oncology
Zip code 104-0045
Address Tsukiji 5-1-1, Chuo-ku, Tokyo, Japan
TEL 03-3542-2511
Email tatyoshi@ncc.go.jp

Public contact
Name of contact person
1st name Tatsuya
Middle name
Last name Yoshida
Organization National Cancer Center Hospital
Division name Department of thoracic oncology
Zip code 104-0045
Address Tsukiji 5-1-1, Chuo-ku, Tokyo, Japan
TEL 03-3542-2511
Homepage URL
Email tatyoshi@ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Reserch 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 National Cancer Center Hospital
Address Tsukiji 5-1-1, Chuo-ku, Tokyo, Japan
Tel 03-3542-2511
Email ncch-irb@ml.res.ncc.go.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
2021 Year 01 Month 20 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 Open public recruiting
Date of protocol fixation
2019 Year 12 Month 16 Day
Date of IRB
2019 Year 12 Month 16 Day
Anticipated trial start date
2019 Year 12 Month 16 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2021 Year 01 Month 20 Day
Last modified on
2021 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049169

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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