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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034952
Receipt No. R000039855
Scientific Title Liquid Biopsy of Durvalmab for locally advanced NSCLC
Date of disclosure of the study information 2018/11/20
Last modified on 2019/03/22

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Basic information
Public title Liquid Biopsy of Durvalmab for locally advanced NSCLC
Acronym Liquid Biopsy of Durvalmab for locally advanced NSCLC
Scientific Title Liquid Biopsy of Durvalmab for locally advanced NSCLC
Scientific Title:Acronym Liquid Biopsy of Durvalmab for locally advanced NSCLC
Region
Japan

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

Objectives
Narrative objectives1 To explore expressions of immune-related proteins before- and after chemoradiotherapy follow by durvalmab for locally advanced non-small cell lung cancer
Basic objectives2 Others
Basic objectives -Others Clinical outcomes (progression-free survival, overall survival, and safety)
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To explore expressions of immune-related proteins before- and after chemoradiotherapy follow by durvalmab for locally advanced non-small cell lung cancer
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients treated with chemoradiotherapy followed by durvalmab for advanced NSCLC
Key exclusion criteria none
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yusuke
Middle name
Last name Okuma
Organization Tokyo Metropolitan Komagome Hospital
Division name Department of Thoracic Oncology
Zip code 113-8677
Address 3-18-22, Honkomgaome, Bunkyo, tokyo
TEL 03-3823-2101
Email y-okuma@cick.jp

Public contact
Name of contact person
1st name Shoko
Middle name
Last name Kawai
Organization Tokyo Metropolitan Komagome Hospital
Division name Department of Thoracic Oncology
Zip code 113-8677
Address 3-18-22, Honkomgaome, Bunkyo, tokyo
TEL 03-3823-2101
Homepage URL
Email y-okuma@cick.jp

Sponsor
Institute Tokyo Metropolitan Komagome Hospital
Institute
Department

Funding Source
Organization Tokyo Metropolitan Komagome Hospital
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 Ethics committee of Tokyo Metropolitan Komagome Hospital
Address Honkomagome 3-18-22, Bunkyo, Tokyo
Tel 03-3823-2101
Email rinri@cick.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
2018 Year 11 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 Enrolling by invitation
Date of protocol fixation
2018 Year 09 Month 25 Day
Date of IRB
2018 Year 09 Month 26 Day
Anticipated trial start date
2018 Year 09 Month 26 Day
Last follow-up date
2026 Year 09 Month 24 Day
Date of closure to data entry
2026 Year 09 Month 24 Day
Date trial data considered complete
2026 Year 09 Month 24 Day
Date analysis concluded

Other
Other related information observational study

Management information
Registered date
2018 Year 11 Month 20 Day
Last modified on
2019 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039855

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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