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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031472
Receipt No. R000035922
Scientific Title Analysis of the mechanisms of acquired resistance to molecular-targeted therapy in lung cancer using liquid biopsy of circulating nucleotide acids and circulating tumor cells
Date of disclosure of the study information 2018/03/01
Last modified on 2018/02/25

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Basic information
Public title Analysis of the mechanisms of acquired resistance to molecular-targeted therapy in lung cancer using liquid biopsy of circulating nucleotide acids and circulating tumor cells
Acronym Analysis of the mechanisms of acquired resistance to molecular-targeted therapy in lung cancer using liquid biopsy of circulating nucleotide acids and circulating tumor cells
Scientific Title Analysis of the mechanisms of acquired resistance to molecular-targeted therapy in lung cancer using liquid biopsy of circulating nucleotide acids and circulating tumor cells
Scientific Title:Acronym Analysis of the mechanisms of acquired resistance to molecular-targeted therapy in lung cancer using liquid biopsy of circulating nucleotide acids and circulating tumor cells
Region
Japan

Condition
Condition Lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Analysis of biopsy specimen, circulating tumor cells and cell free DNA
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes gene analysis
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 Pathologically proven lung cancer with EGFR mutation
A re-biopsy was planned within 2 weeks after progression under EGFR-TKI treatment
written informed consent
Key exclusion criteria inappropriate participation judged by the attending physician
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsunari Hase
Organization Nagoya University Hospital
Division name Department of Respiratory Medicine
Zip code
Address 65 tsurumai-cho, showa-ku, nagoya
TEL 052-741-2111
Email thase@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsunari Hase
Organization Nagoya University Hospital
Division name Department of Respiratory Medicine
Zip code
Address 65 tsurumai-cho, showa-ku, nagoya
TEL 052-741-2111
Homepage URL
Email thase@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization Boehringer Ingelheim
Organization
Division
Category of Funding Organization Profit organization
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
2018 Year 03 Month 01 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
2016 Year 10 Month 12 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is a prospective observational study.

Management information
Registered date
2018 Year 02 Month 25 Day
Last modified on
2018 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035922

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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