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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036149
Receipt No. R000041153
Scientific Title Prospective observational study of EGFR mutation allele frequency using Cell free DNA
Date of disclosure of the study information 2019/03/13
Last modified on 2019/06/04

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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
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
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
2019 Year 06 Month 04 Day


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

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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