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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031013
Receipt No. R000035406
Scientific Title A study of the resistance mechanism of EGFR-TKI in EGFR gene mutation positive non-small cell lung cancer
Date of disclosure of the study information 2018/03/01
Last modified on 2018/09/05

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Basic information
Public title A study of the resistance mechanism of EGFR-TKI in EGFR gene mutation positive non-small cell lung cancer
Acronym A study of the resistance mechanism of EGFR-TKI
Scientific Title A study of the resistance mechanism of EGFR-TKI in EGFR gene mutation positive non-small cell lung cancer
Scientific Title:Acronym A study of the resistance mechanism of EGFR-TKI
Region
Japan

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

Objectives
Narrative objectives1 To explore for anomalies in genes and proteins that can be candidates for the resistance factor of afatinib
Basic objectives2 Others
Basic objectives -Others To explore for genes and protein abnormalities affecting progression free survival, response rate, rate of disease control in afatinib therapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Potential predictive anomalies in genes and proteins that can be candidates for the resistance factor of afatinib
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 1. Patients has been confirmed histologically or cytologically non-small cell lung cancer.
2. Patients planning to treat Afacinib or first generation EGFR-TKI.
3. Patients where tissues can be harvested for this study prior to afatinib or first generation EGFR-TKI treatment and resistance.
4. The PS of ECOG is 0 or 1.
5. There are no major obstacles in major organs (bone marrow, heart, lung, liver, kidney etc.).
6. Patient that is expected to survive for at least 3 months.
7. Patients in which consent has been obtained in the document for this study.
8. The age at registration is 20 years or older.
9. Participants in "prospective observational research (LC-SCRUM)" to clarify the clinicopathological and molecular biological characteristics of low-frequency genetic change positive lung cancer such as RET fusion gene.
Key exclusion criteria Patients otherwise considered unsuitable to participate in this study by investigators at study sites
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junji Uchino
Organization Kyoto prefectural University of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5513
Email uchino@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keiko Tanimura
Organization Kyoto prefectural University of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto 602-8566, Japan
TEL 075-251-5513
Homepage URL
Email keiko-t@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto prefectural University of Medicine
Institute
Department

Funding Source
Organization Boehringer Ingelheim Japan, Inc.
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
2018 Year 01 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 05 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 01 Month 26 Day
Last modified on
2018 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035406

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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