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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037133
Receipt No. R000042320
Scientific Title Detecting low allele frequency of compound minor mutation using high-sensitivity next generation sequencer for EGFR mutant lung cancer
Date of disclosure of the study information 2019/06/21
Last modified on 2019/06/21

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Basic information
Public title Detecting low allele frequency of compound minor mutation using high-sensitivity next generation sequencer for EGFR mutant lung cancer
Acronym Detecting compound minor mutation using NGS for EGFR mutant lung cancer
Scientific Title Detecting low allele frequency of compound minor mutation using high-sensitivity next generation sequencer for EGFR mutant lung cancer
Scientific Title:Acronym Detecting compound minor mutation using NGS for EGFR mutant lung cancer
Region
Japan

Condition
Condition EGFR-mutant lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The aim of this study is to prospectively investigate detecting rate of EGFR compound minor mutation containing Ex20 T790M using high-sensitivity NGS at diagnostic phase and re-biopsy phase to compare the subsequence genetic change.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Detection rate of EGFR compound minor mutation using NGS
Key secondary outcomes 1) Allele frequency of sensitive mutation and compound minor mutation, and its corelation for response rate and PFS.
2) T790M detection rate at diagnostic phase and re-biopsy phase
3) Subsequent allele frequency change of EGFR compound minor mutation

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) EGFR-mutant lung cancer
2) Written informed consent
Key exclusion criteria Other cases attending physician it is determined unsuitable for registration of the study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Kei
Middle name
Last name Morikawa
Organization St. Marianna University School of Medicine
Division name Division of Respiratory Diseases, Department of Internal Medicine
Zip code 216-8511
Address 2-16-1 Sugao Miyamae-ku, Kawasaki
TEL 044-977-8111
Email mokke5454@yahoo.co.jp

Public contact
Name of contact person
1st name Kei
Middle name
Last name Morikawa
Organization St. Marianna University School of Medicine
Division name Division of Respiratory Diseases, Department of Internal Medicine
Zip code 216-8511
Address 2-16-1 Sugao Miyamae-ku, Kawasaki
TEL 044-977-8111
Homepage URL
Email mokke5454@yahoo.co.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization Boehringer Ingelheim GmbH
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 St. Marianna University School of Medicine
Address 2-16-1 Sugao Miyamae-ku, Kawasaki
Tel 044-977-8111
Email mokke5454@yahoo.co.jp

Secondary IDs
Secondary IDs YES
Study ID_1 #4395
Org. issuing International ID_1 St. Marianna University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 聖マリアンナ医科大学

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 21 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
2019 Year 05 Month 01 Day
Date of IRB
2019 Year 06 Month 13 Day
Anticipated trial start date
2019 Year 06 Month 21 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information ongoing

Management information
Registered date
2019 Year 06 Month 21 Day
Last modified on
2019 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042320

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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