UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040432 |
|---|---|
| Receipt number | R000046142 |
| Scientific Title | A prospective observational study of osimertinib as predictive marker against patients with EGFR mutation positive NSCLC. |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2020/05/18 14:58:58 |
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Basic information
Public title
A prospective observational study of osimertinib as predictive marker against patients with EGFR mutation positive NSCLC.
Acronym
A prospective observational study of osimertinib as predictive marker against patients with EGFR mutation positive NSCLC.
Scientific Title
A prospective observational study of osimertinib as predictive marker against patients with EGFR mutation positive NSCLC.
Scientific Title:Acronym
A prospective observational study of osimertinib as predictive marker against patients with EGFR mutation positive NSCLC.
Region
| Japan |
Condition
Condition
Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To predict the efficacy and therapeutic resistance of Osimertinib by the quantitative amount of EGFR active mutation and C797S.
To explore the possibility of PIK3CA, BRAF, beta-catenin, MET and HER2 as a chemoresistant marker of Osimertinib
using blood and biopsy sample.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endpoint:To predict the efficacy of osimertinib according to quantitative amount ofEGFR mutation expression.
Secandary endpoint:To predict the efficacy of osimertinib according to quantitative amount of C797S.
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) Pathologically confirmation of non small cell lung cancer
2) EGFR gene mutation has been examined and administration of osimertinib is planned
3) ECOG-PS 0-2
4) Adequate organ functions
5) Expected survival over 12 weeks
6) Written informed consent
Key exclusion criteria
1)Active double cancer
2)Interstitial pneumonitis on chest CT
3)Active infectious disease
4) Not approbed for blood sampling
5) Plegnant woman
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Norimitsu |
| Middle name | |
| Last name | Kasahara |
Organization
Gunma University Hospital
Division name
Innovative Medical Center
Zip code
371-8511
Address
3-39-15, Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-8222
m14702016@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Norimitsu |
| Middle name | |
| Last name | Kasahara |
Organization
Gunma University Hospital
Division name
Innovative Medical Center
Zip code
371-8511
Address
3-39-15, Showa-machi, Maebashi, Gunma, Japan
TEL
027-220-8222
Homepage URL
m14702016@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma Institutional Review Board
Address
3-39-15, Showa-machi, Maebashi, Gunma, Japan
Tel
027-220-7111
ciru_hitotaisho-irb@ml.gunma-u.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
| 2020 | Year | 06 | 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 | 09 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observation study
Management information
Registered date
| 2020 | Year | 05 | Month | 18 | Day |
Last modified on
| 2020 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046142
