UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021802 |
|---|---|
| Receipt number | R000025009 |
| Scientific Title | Research for elucidating the resistance mechanism to RET tyrosine kinase inhibitors in patients with non-small-cell lung cancer harboring with RET fusion gene |
| Date of disclosure of the study information | 2016/04/12 |
| Last modified on | 2016/10/11 12:09:12 |
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Basic information
Public title
Research for elucidating the resistance mechanism to RET tyrosine kinase inhibitors in patients with non-small-cell lung cancer harboring with RET fusion gene
Acronym
Research for RET-TKI resistance in NSCLC harboring with RET fusion gene
Scientific Title
Research for elucidating the resistance mechanism to RET tyrosine kinase inhibitors in patients with non-small-cell lung cancer harboring with RET fusion gene
Scientific Title:Acronym
Research for RET-TKI resistance in NSCLC harboring with RET fusion gene
Region
| Japan |
Condition
Condition
Advanced non-small-cell lung cancer harboring with RET fusion gene
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To elucidate the resistance mechanism to RET-TKI alectinib in NSCLC harboring with RET fusion gene
Basic objectives2
Others
Basic objectives -Others
To elucidate the resistance mechanism to RET-TKI alectinib in NSCLC harboring with RET fusion gene using clinical sample before and after alectinib
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To find out the resistance mechanism to RET-TKI alectinib in NSCLC harboring with RET fusion gene
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. Written informed consent
2. Histologically or cytologically diagnosed NSCLC
3. Unresectable locally advanced or metastatic disease
4. Tumor samples test positive for a RET fusion gene
5. Testing negative for an EGFR mutation
6. Testing negative for an ALK fusion gene
Key exclusion criteria
1. Having previously received alectinib
2.Patients whom an investigator deems ineligible for participation in this study for some other reason.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiji Yano |
Organization
Cancer Research Institute, Kanazawa University
Division name
Medical Oncology
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa 920-0934
TEL
076-265-2794
syano@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadaaki Yamada |
Organization
Cancer Research Institute, Kanazawa University
Division name
Medical Oncology
Zip code
Address
13-1 Takara-machi, Kanazawa, Ishikawa 920-0934
TEL
076-265-2794
Homepage URL
tadaakiy@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Cancer Research Institute, Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hokkaido University
National Cancer Center Hospital East
The Cancer Institute Hospital of JFCR
Tokyo University
Nagoya University Hospital
Hyogo Cancer Center
Okayama University Hospital
National Hospital Organization Kyushu Cancer Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
北海道大学大学院医学系研究科(北海道)
国立がん研究センター東病院(千葉県)
がん研究会有明病院(東京都)
東京大学大学院医学系研究科(東京都)
名古屋大医学部附属病院(愛知県)
金沢大学附属病院(石川県)
兵庫県立がんセンター(兵庫県)
岡山大学病院(岡山県)
国立病院機構 九州がんセンター(福岡県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 12 | 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
| 2016 | Year | 02 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
To elucidate the resistance mechanism to RET-TKI alectinib using DNA, RNA, and proteins derived from clinical samples in patients with non-small-cell lung cancer harboring with RET fusion gene
Management information
Registered date
| 2016 | Year | 04 | Month | 06 | Day |
Last modified on
| 2016 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025009
| Research Plan | |
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| 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 |
