UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002193 |
|---|---|
| Receipt number | R000002692 |
| Scientific Title | The study to evaluate the efficacy and resistance for EGFR-TKIs treatment in lung cancer patients. |
| Date of disclosure of the study information | 2009/07/14 |
| Last modified on | 2011/08/15 15:26:55 |
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Basic information
Public title
The study to evaluate the efficacy and resistance for EGFR-TKIs treatment in lung cancer patients.
Acronym
The study to evaluate the efficacy and resistance for EGFR-TKIs treatment in lung cancer patients.
Scientific Title
The study to evaluate the efficacy and resistance for EGFR-TKIs treatment in lung cancer patients.
Scientific Title:Acronym
The study to evaluate the efficacy and resistance for EGFR-TKIs treatment in lung cancer patients.
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
We plan this study to investigate the efficacy and resistance for EGFR-TKIs treatment. We mesure EGFR mutations, MET amplification and the other genomic profiles using the samples obtained from before treatment/ after resistant.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
corrlation of genomic profile and efficacy and resistance
Key secondary outcomes
adverse ivent, survival, patinets characteristics
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
EGFR-TKIs, analysis of genomic profiles
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
Lung cancer patients with EGFR-TKIs. All patients give written informed consent.
Key exclusion criteria
except for the above-mentioned
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoichi Nakamura |
Organization
Nagasaki-university hospital
Division name
second depertment of internal medisine
Zip code
Address
1-7-1 Sakamoto, Nagasaki 852-8501, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
NTOG
Division name
Nagasaki-university hospital
Zip code
Address
TEL
095-819-7273
Homepage URL
Sponsor or person
Institute
Second Department of Internal Medicine, 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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 07 | Month | 14 | 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
| 2009 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 13 | Day |
Last modified on
| 2011 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002692
