UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031013 |
|---|---|
| Receipt number | 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 | 2020/07/29 13:13:49 |
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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 | Junji |
| Middle name | |
| Last name | Uchino |
Organization
Kyoto prefectural University of Medicine
Division name
Department of Respiratory Medicine
Zip code
6020841
Address
465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5513
uchino@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Tanimura |
Organization
Kyoto prefectural University of Medicine
Division name
Department of Respiratory Medicine
Zip code
6020841
Address
465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto 602-8566, Japan
TEL
075-251-5513
Homepage URL
keiko-t@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto prefectural University of Medicine
Institute
Department
Personal name
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
Kyoto prefectural University of Medicine
Address
465 Kajii-cho, Hirokoji-agaru, Kawaramachi-dori, Kamigyo-ku, Kyoto 602-8566, Japan
Tel
075-251-5513
uchino@koto.kpu-m.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
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
| 2018 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
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
| 2020 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035406
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
