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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041252
Receipt No. R000047107
Scientific Title The incidence of resistant mechanism among epidermal growth factor receptor tyrosine kinase inhibitors in non-small cell lung cancer patients after disease progression of prior treatments
Date of disclosure of the study information 2020/07/29
Last modified on 2020/07/29

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Basic information
Public title The incidence of resistant mechanism among epidermal growth factor receptor tyrosine kinase inhibitors in non-small cell lung cancer patients after disease progression of prior treatments
Acronym The incidence of resistant mechanism among epidermal growth factor receptor tyrosine kinase inhibitors in non-small cell lung cancer patients after disease progression of prior treatments
Scientific Title The incidence of resistant mechanism among epidermal growth factor receptor tyrosine kinase inhibitors in non-small cell lung cancer patients after disease progression of prior treatments
Scientific Title:Acronym The incidence of resistant mechanism among epidermal growth factor receptor tyrosine kinase inhibitors in non-small cell lung cancer patients after disease progression of prior treatments
Region
Japan

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

Objectives
Narrative objectives1 To clarify the incidence of EGFR-TKI resistance mechanism by each treatment
Basic objectives2 Others
Basic objectives -Others Frequency of resistance mechanism due to gene mutation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Incidence of each resistant mechanisms to EGFR-TKI
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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 Patients who analyzed for the resistant mechanism to EGFR-TKI
Key exclusion criteria Patients who excluded from studies
Target sample size

Research contact person
Name of lead principal investigator
1st name Nobuaki
Middle name
Last name Kobayashi
Organization Yokohama City University Graduate School of Medicine
Division name Department of Pulmonology
Zip code 236-0004
Address Kanazawaku, Yokohama
TEL +81453527962
Email nkobayas@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Nobuaki
Middle name
Last name Kobayashi
Organization Yokohama City University
Division name Department of Pulmonogy
Zip code 2360004
Address 3-9 Fukuura, Kanazawaku, Yokohama
TEL +81453527962
Homepage URL
Email nkobayas@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization None
Address None
Tel None
Email None

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
2020 Year 07 Month 29 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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 29 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 29 Day
Last follow-up date
2020 Year 10 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study Search
Studyies will be systematically searched through PubMed, the Cochrane database and Web of Science as of July 29, 2020.

The search strategy for PubMed will be as follows:
(resistance OR resistant) AND (egfr OR epidermal growth factor receptor) AND (lung cancer [Title] OR lung carcinoma [Title] OR NSCLC[Title])
Limit English

The search strategy for Web of science will be as follows:
#1 TS= ((resistance OR resistant) AND (egfr OR epidermal growth factor receptor))
#2 TI= (lung cancer OR lung carcinoma OR NSCLC)
#3 #1 AND #2
Limit English

The search strategy for Cochrane will be as follows:
#1 All Text = ((resistance OR resistant) AND (egfr OR epidermal growth factor receptor))
#2 Title Abstract Keyword = (lung cancer OR lung carcinoma OR NSCLC)
#3 #1 AND #2
Excluding Cochrane review and Cochrane protocol

Reference lists in the included articles and review articles will be also hand searched.

Data synthesis
The incidence of resistant mechanisms will be pooled. Synthesized data will be analyzed with each EGFR-TKIs.
Statistical significance will be judged by P < 0.05.

Management information
Registered date
2020 Year 07 Month 29 Day
Last modified on
2020 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047107

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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