UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033567 |
|---|---|
| Receipt number | 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 06:10:26 |
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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
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
h.kenmotsu@scchr.jp
Sponsor or person
Institute
Shizuoka Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038146
