UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031326 |
|---|---|
| Receipt number | R000035744 |
| Scientific Title | Efficacy of macrodissection for detecting EGFR mutation by cobas test |
| Date of disclosure of the study information | 2018/02/15 |
| Last modified on | 2023/09/09 22:50:51 |
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Basic information
Public title
Efficacy of macrodissection for detecting EGFR mutation by cobas test
Acronym
Macrodissection for detecting EGFR mutation
Scientific Title
Efficacy of macrodissection for detecting EGFR mutation by cobas test
Scientific Title:Acronym
Macrodissection for detecting EGFR mutation
Region
| Japan |
Condition
Condition
Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the positive rate of EGFR mutation by cobas test before and after macrodissection of bronchoscopic samples with EGFR mutation with PCR Clump.
Basic objectives2
Others
Basic objectives -Others
Sensitivity
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The positive rate of EGFR mutation by cobas test before and after macrodissection of bronchoscopic samples with EGFR mutation with PCR Clump.
Key secondary outcomes
Comparing the rate of tumor area to the whole sample on the slide in both EGFR positive samples and negative samples with cobas test.
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
EGFR positive lung cancer samples detected by PCR Clump test from January 2007 to January 2017 at the first biopsy by bronchoscopy.
Improve version of the PCR Clump test was introduced in October 2013 in our hospital. All the samples before the introduction are retested in the improved version and included when positive.
Key exclusion criteria
Patient who reject to be included.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Mariko |
| Middle name | |
| Last name | Kogo |
Organization
Kobe City Medical Center General Hospital
Division name
Respiratory Medicine
Zip code
6500047
Address
2-1-1, Minatojima-minanimachi, Chuo-ku, Japan
TEL
078-302-4321
m_k_o_g_o@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mariko |
| Middle name | |
| Last name | Kogo |
Organization
Kobe City Medical Center General Hospital
Division name
Respiratory Medicine
Zip code
6500047
Address
2-1-1, Minatojima-minanimachi, Chuo-ku, Japan
TEL
078-302-4321
Homepage URL
m_k_o_g_o@yahoo.co.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca
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
Institutional Review Board of Kobe City Medical Centre General Hospital
Address
2-1-1, Minatojima minamimachi, Chuo-ku, Kobe, Japan
Tel
078-302-4321
rinken@kcho.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
| 2018 | Year | 02 | Month | 15 | 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
132
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
Main results already published
Date of protocol fixation
| 2017 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The block of the subject were sliced and checked for EGFR status with cobas test (the block which were takend before Oct 2013 were re-checked with PCR Clump test).The amonunt of tumour the specimen contains were also pathologically evaluated.
The secpimen with positive EGFR by PCR-Clump test and negative by cobas test were sliced additionally and re-chekced for EGFR status with cobas test after tumor dissection on the slide.
Management information
Registered date
| 2018 | Year | 02 | Month | 15 | Day |
Last modified on
| 2023 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035744
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
