UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025290 |
|---|---|
| Receipt number | R000029086 |
| Scientific Title | Observational biomarker study related to the resistance mechanism of 3rd generation EGFR-TKI (osimertinib)(LOGIK1607) |
| Date of disclosure of the study information | 2016/12/15 |
| Last modified on | 2021/07/10 10:06:09 |
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Basic information
Public title
Observational biomarker study related to the resistance mechanism of 3rd generation EGFR-TKI (osimertinib)(LOGIK1607)
Acronym
Observational biomarker study related to the resistance mechanism of osimertinib (LOGIK1607)
Scientific Title
Observational biomarker study related to the resistance mechanism of 3rd generation EGFR-TKI (osimertinib)(LOGIK1607)
Scientific Title:Acronym
Observational biomarker study related to the resistance mechanism of osimertinib (LOGIK1607)
Region
| Japan |
Condition
Condition
EGFR mutation positive and T790M positive non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We investigate known or novel factors regarding 3rd generation EGFR-TKI (osimertinib) acquired resistance (AR) mechanisms in EGFR mutation positive lung cancer and analyze the correlation between the factors and the clinicopathological data as biomarker research of osimertinib AR.
Basic objectives2
Others
Basic objectives -Others
Gene analysis, protein expression analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gene analysis using next generation sequencing and protein expression analysis using immunohistochemistry
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
1. Paraffin embedded specimen
The specimen collected from a lesion at the confirmation of progression disease after osimertinib treatment is submitted with the specimen before osimertinib treatment.
2. Blood sample
Blood sample is collected after PD confirmation.
Gene analysis: DNA and RNA are extracted from formalin-fixed paraffin-embedded (FFPE) tissue slice and a detection of somatic gene mutation is performed using next generation sequencer, ionPGM. The somatic mutation, copy number variants and fusion drivers of 143 genes of interest are measured using Oncomine Cancer Research Panel (OCP, Thermo Fisher Scientific Inc.).
cfDNA analysis: cfDNA is extracted from plasma and the somatic gene mutation, copy number variants are measured using a custom panel on ionPGM platform.
Protein expression analysis: The quantitative or qualitative measurement of protein related to immune checkpoints (such as PD-L1/ PD-1, Foxp3) is performed using immunohistochemical staining of FFPE.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Primary enrollment: The eligible patients are lung cancer patients whose formalin-fixed paraffin-embedded biopsy samples before osimertinib treatment are proven to have EGFR T790M mutation and who are planned to receive or receiving osimertinib treatment. The pre-treatment sample have to meet the "species and quantity of the sample" criteria.
Secondary enrollment: Patients whose tumor tissue samples are available at the confirmation of progression disease after durable response to osimertinib treatment (documented PR/CR or SD for more than 6 months determined by RECIST or WHO criteria) and who are not started other anti-tumor treatment (chemotherapy, radiotherapy, immunotherapy) are eligible. Patients with adhesion therapy by minomycin, OK-432 and talc for coelomic fluid retention are also eligible.
The sample have to meet the "species and quantity of the sample" criteria.
Key exclusion criteria
Patients who receive osimertinib concurrently with other cytotoxic agents, molecular targeting agents or immune-checkpoint inhibitors are excluded. Patients whose tumor specimens cannot meet the eligibility criteria or the "paired" specimens (pre and post osimertinib treatment) cannot be submitted are also excluded.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Sugio |
Organization
Oita University Faculty of Medicine
Division name
Department of Thoracic and Breast Surgery
Zip code
Address
1-1 Idaigaoka, Hasama-machi, Yufu, Oita 879-5593, Japan
TEL
097-586-5854
ksugio@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Osoegawa |
Organization
Oita University Faculty of Medicine
Division name
Department of Thoracic and Breast Surgery
Zip code
Address
1-1 Idaigaoka, Hasama-machi, Yufu, Oita 879-5593, Japan
TEL
097-586-5854
Homepage URL
osoegawa-ths@oita-u.ac.jp
Sponsor or person
Institute
Clinical Research Support Center Kyushu
Institute
Department
Personal name
Funding Source
Organization
Astra Zenaca
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
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 15 | 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
Main results already published
Date of protocol fixation
| 2016 | Year | 10 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 15 | Day |
Last modified on
| 2021 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029086
