UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021860
Receipt No. R000025205
Scientific Title Exploratory study on detecting EGFR mutation including T790M with blood samples from patients with advanced non-small cell lung cancer after EGFR-TKI failure
Date of disclosure of the study information 2016/04/11
Last modified on 2016/04/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Exploratory study on detecting EGFR mutation including T790M with blood samples
from patients with advanced non-small cell lung cancer after EGFR-TKI failure
Acronym EGFR mutation analysis including T790M for blood samples
Scientific Title Exploratory study on detecting EGFR mutation including T790M with blood samples
from patients with advanced non-small cell lung cancer after EGFR-TKI failure
Scientific Title:Acronym EGFR mutation analysis including T790M for blood samples
Region
Japan

Condition
Condition Advanced non-small cell lung cancer with EGFR mutation
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the procedure for detecting EGFR T790M mutation with blood samples
from patients refractory to EGFR-TKI as alternative method of re-biopsy from tissue samples
Basic objectives2 Others
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Detection rate of EGFR mutations including T790M in plasma
Key secondary outcomes 1) Concordance of EGFR mutation status between tissue samples and plasma
2) Correlation between EGFR mutation status and clinical background

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Pathologically confirmation of non-small cell lung cancer
2) EGFR gene mutations are identified
3) Refractory to EGFR-TKI monotherapy or combination therapy
4) Written informed consent
Key exclusion criteria Not applicable
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruyasu Murakami
Organization Shizuoka cancer center
Division name Devision of Thoracic Oncology
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan.
TEL (+81)055-989-5222
Email ha.murakami@scchr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahisa Kawamura/ Murakami Haruyasu
Organization Shizuoka cancer center
Division name Devision of Thoracic Oncology
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan.
TEL (+81)055-989-5222
Homepage URL
Email ta.kawamura@scchr.jp

Sponsor
Institute Shizuoka cancer center
Institute
Department

Funding Source
Organization Shizuoka cancer center
Organization
Division
Category of Funding Organization Other
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 04 Month 11 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 03 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Nothing particular

Management information
Registered date
2016 Year 04 Month 10 Day
Last modified on
2016 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025205

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.