UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018150 |
|---|---|
| Receipt number | R000021021 |
| Scientific Title | Examination of having T790M or not after the EGFR-TKI tolerance in the EGFR gene variation-positive progress non-small-cell lung cancer |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2019/07/05 14:52:22 |
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Basic information
Public title
Examination of having T790M or not after the EGFR-TKI tolerance in the EGFR gene variation-positive progress non-small-cell lung cancer
Acronym
Examination of having T790M or not after the EGFR-TKI tolerance in the EGFR gene variation-positive progress non-small-cell lung cancer
Scientific Title
Examination of having T790M or not after the EGFR-TKI tolerance in the EGFR gene variation-positive progress non-small-cell lung cancer
Scientific Title:Acronym
Examination of having T790M or not after the EGFR-TKI tolerance in the EGFR gene variation-positive progress non-small-cell lung cancer
Region
| Japan |
Condition
Condition
Non-Small-Cell Lung Cancer
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We examine having T790M or not after the EGFR-TKI tolerance in the EGFR gene variation-positive progress non-original squamous epithelium non-small-cell lung cancer. In addition, We examine the effectiveness, safety of EGFR-TKI after the second treatment.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Having gene variation or not
Key secondary outcomes
Response rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Gene |
Interventions/Control_1
Examination with bronchoscope and CT-guided needle biopsy
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.Histologically or cytologically proven non-small cell lung cancer
2.After EGFR gene variation was positive and EGFR-TKI was effective, a condition progressed
Key exclusion criteria
1.Serious medical complications
2.uncontrolled angina pectoris,myocardial infarction within 3 months, heart failure.
3.serious infectious diseases
4.Other clinical difficulties to this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsumi Nakatomi |
Organization
Nagasaki University Hospital
Division name
Second Department of Internal Medicine
Zip code
Address
1-7-1 Sakamoto, Nagasaki city, Nagasaki, Japan
TEL
095-819-7273
dear_tm_1016_612@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Midori Shimada |
Organization
Nagasaki University Hospital
Division name
Second Department of Internal Medicine
Zip code
Address
1-7-1 Sakamoto, Nagasaki city, Nagasaki, Japan
TEL
095-819-7273
Homepage URL
dear_tm_1016_612@yahoo.co.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
長崎大学病院(長崎県)、日本赤十字社長崎原爆病院(長崎県)、
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 01 | 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
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 01 | Day |
Last modified on
| 2019 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021021
| 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 |
