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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033567
Receipt No. R000038146
Scientific Title Study on the detection of EGFR mutation using the high sensitive PCR method in lung cancer
Date of disclosure of the study information 2018/07/31
Last modified on 2018/07/31

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Basic information
Public title Study on the detection of EGFR mutation using the high sensitive PCR method in lung cancer
Acronym Study on the detection of EGFR mutation
Scientific Title Study on the detection of EGFR mutation using the high sensitive PCR method in lung cancer
Scientific Title:Acronym Study on the detection of EGFR mutation
Region
Japan

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

Objectives
Narrative objectives1 detection of EGFR mutation using plasma DNA in patients with lung cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Detect the exon 19 deletion, the L858R mutation in EGFR exon 21 and T790M mutation in EGFR exon 20
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)advanced or recurrent NSCLC harboring common EGFR mutations (exon 19 deletions, and the L858R mutation in exon 21) confirmed by the Scorpion Amplified Refractory Mutation System (ARMS) method;
(2) prior to the start of EGFR-TKI treatment or disease progression after EGFR-TKI treatment;
(3) allowing the collection and genomic analysis of blood samples (20 mL);
(4) able to provide written informed consent.
Key exclusion criteria None
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Koh
Organization Wakayama Medical University
Division name Third Department of Internal Medicine
Zip code
Address 811-1 Kimiidera, Wakayama-shi, Wakayama
TEL 073-441-0619
Email ykoh@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirotsugu Kenmotsu
Organization Shizuoka Cancer Center
Division name Division of Thoracic Oncology
Zip code
Address 1007 Shimonagakubo, Nagaizumi-cho. Sunto-gun, Shizuoka
TEL 0559895222
Homepage URL
Email h.kenmotsu@scchr.jp

Sponsor
Institute Shizuoka Cancer Center
Institute
Department

Funding Source
Organization Japan Science and Technology Agency Center for Revitalization Promotion.
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor G&G SCIENCE CO., LTD
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 静岡県立静岡がんセンター

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2013 Year 10 Month 08 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 49 patients were enrolled and became the end of the study.

Management information
Registered date
2018 Year 07 Month 31 Day
Last modified on
2018 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038146

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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