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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040448
Receipt No. R000046162
Scientific Title HISTOlogic transfoRmatIon of EGFR-mutant lung Cancer in the real-world setting. HISTORIC study
Date of disclosure of the study information 2020/05/19
Last modified on 2020/05/19

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Basic information
Public title HISTOlogic transfoRmatIon of EGFR-mutant lung Cancer in the real-world setting.
HISTORIC study
Acronym HISTORIC
Scientific Title HISTOlogic transfoRmatIon of EGFR-mutant lung Cancer in the real-world setting.
HISTORIC study
Scientific Title:Acronym HISTORIC
Region
Japan

Condition
Condition Non-small cell lung cancer with mutated EGFR
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the current incidence of histologic transformation, characteristics and drug treatment effect after EGFR-TKI treatment in EGFR mutation positive lung cancer in Japan
Basic objectives2 Others
Basic objectives -Others the incidence of histologic transformation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes incidence of histologic transformation
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
120 years-old >
Gender Male and Female
Key inclusion criteria 1.EGFR mutation-positive advanced stage lung cancer(TNM classification 8th edition)
2.Patients who started EGFR-TKI from January 1, 2012 to December 31, 2019
Key exclusion criteria no criteria
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name Daichi
Middle name
Last name Fujimoto
Organization Wakayama medical university
Division name Internal medicine III
Zip code 641-8509
Address 811-1, kimiidera, Wakayama
TEL 073-441-0619
Email daichi@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Daichi
Middle name
Last name Fujimoto
Organization Wakayama medical university
Division name Internal medicine III
Zip code 641-8509
Address 811-1, kimiidera, Wakayama
TEL 073-441-0619
Homepage URL
Email daichi@wakayama-med.ac.jp

Sponsor
Institute Wakayama medical university
Institute
Department

Funding Source
Organization self-funding
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 Wakayama medical university
Address 811-1, kimiidera, Wakayama
Tel 073-441-0619
Email wa-rinri@wakayama-med.ac.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 神戸市立医療センター中央市民病院
兵庫医科大学病院
千葉大学医学部附属病院
神戸低侵襲がん医療センター
大阪国際がんセンター
近畿中央呼吸器センター
大阪はびきの医療センター
兵庫県立尼崎総合医療センター
倉敷中央病院
市立伊丹病院
大阪刀根山医療センター
東北大学病院
熊本大学病院
姫路医療センター
済生会熊本病院
愛知県がんセンター病院
東京都立駒込病院
福島県立医科大学附属病院
新潟県立がんセンター新潟病院
弘前大学医学部附属病院
聖マリアンナ医科大学病院
君津中央病院
南和歌山医療センター
鳥取大学医学部附属病院
静岡県立静岡がんセンター
大分県立病院
済生会宇都宮病院
亀田総合病院
手稲渓仁会病院
兵庫県立がんセンター
大阪赤十字病院

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 19 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
2020 Year 05 Month 01 Day
Date of IRB
2020 Year 05 Month 13 Day
Anticipated trial start date
2020 Year 05 Month 01 Day
Last follow-up date
2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retrospective obserbational study

Management information
Registered date
2020 Year 05 Month 19 Day
Last modified on
2020 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046162

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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