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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025290
Receipt No. 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 2016/12/15

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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
Email 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
Email osoegawa-ths@oita-u.ac.jp

Sponsor
Institute Clinical Research Support Center Kyushu
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2016 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 29 Day
Last follow-up date
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
2016 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029086

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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