UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040448 |
|---|---|
| Receipt number | 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 | 2023/09/26 10:03:47 |
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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
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
daichi@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama medical university
Institute
Department
Personal name
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
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
N/A
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35278824/
Number of participants that the trial has enrolled
6356
Results
In total, 6356 patients were enrolled. In 2624 patients, the histological type was proven by rebiopsy after acquiring resistance to EGFR-TKIs. Among them, 74 patients had HT (incidence rate: 2.8% [95% confidence interval: 2.3%-3.5%]).
Results date posted
| 2023 | Year | 05 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
6356 patients with mutated EGFR
Participant flow
retrospective
Adverse events
N/A
Outcome measures
The rate of histologic transformation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2021 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 05 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
retrospective obserbational study
Management information
Registered date
| 2020 | Year | 05 | Month | 19 | Day |
Last modified on
| 2023 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046162
