UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study of EGFR mutation allele frequency using Cell free DNA
Acronym	EGFR mutation allele frequency study
Scientific Title	Prospective observational study of EGFR mutation allele frequency using Cell free DNA
Scientific Title:Acronym	EGFR mutation allele frequency study
Region	Japan

Condition
Condition	non small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To measure the allele frequency of EGFR mutation using cell free DNA iin patients with L858R mutation positive non-small cell lung cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in EGFR mutation allele frequency
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. Patients with L858R mutation 2. Patients with unresectable or relapsing non small cell lung cancer 3. Patients over 20 years old at consent acquisition date 4. Patients receiving afatinib 5. Patients who can provide blood samples 6. Patients who agreed to participate in this study in writing
Key exclusion criteria	1. Patients with interstitial pneumonia 2. Patients with serious complications 3. Patients with a history of serious hypersensitivity 4. Patients who are judged inappropriate to participate in this study by the research director or research contributor
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Takafumi Middle name Last name Suda
Organization	Hamamatsu University School of Medicine
Division name	Second division, Depertment of Internal Medicine
Zip code	431-3129
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3129 Japan
TEL	053-435-2263
Email	suda@hama-med.ac.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Akahori
Organization	Hamamatsu University School of Medicine
Division name	Second division, Depertment of Internal Medicine
Zip code	431-3129
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3129 Japan
TEL	053-435-2263
Homepage URL
Email	dakahori@hama-med.ac.jp

Sponsor
Institute	Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization	Japan Boehringer Ingelheim Co., Ltd.
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	Hamamatsu University School of Medicine
Address	1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka, 431-3129 Japan
Tel	053-435-2111
Email	rinri@hama-med.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	2019 Year 03 Month 13 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	33
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	No longer recruiting
Date of protocol fixation	2018 Year 11 Month 27 Day
Date of IRB	2019 Year 01 Month 30 Day
Anticipated trial start date	2019 Year 03 Month 13 Day
Last follow-up date	2024 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Multi-center prospective observational study

Management information
Registered date	2019 Year 03 Month 11 Day
Last modified on	2021 Year 03 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041153