UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006764 |
|---|---|
| Receipt number | R000008004 |
| Scientific Title | Prediction of response of EGFR tyrosine kinase inhibtors by plasma DNA |
| Date of disclosure of the study information | 2011/11/24 |
| Last modified on | 2019/05/31 10:25:26 |
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Basic information
Public title
Prediction of response of EGFR tyrosine kinase inhibtors by plasma DNA
Acronym
Prediction of response of EGFR-TKI by plasma DNA
Scientific Title
Prediction of response of EGFR tyrosine kinase inhibtors by plasma DNA
Scientific Title:Acronym
Prediction of response of EGFR-TKI by plasma DNA
Region
| Japan |
Condition
Condition
Lung cancer patients with active EGFR mutations in their tumors
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Time course of EGFR gene change by treatments
Basic objectives2
Others
Basic objectives -Others
Differences of EGFR gene mutations by tumor sites
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EGFR gene change and heterogeneity by treatment and tumor sites
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) Active EGFR mutation, 2) Planning of treatment with 1st or 2nd EGFR-TKI or 1st chemotherapy after 1st EGFR-TKI
Key exclusion criteria
No exclusion
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Fumio |
| Middle name | |
| Last name | Imamura |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Thoracic Oncology
Zip code
5418567
Address
1-3-3 Nakamichi Higashinari-ku, Osaka 537-8511, Japan
TEL
0669721181
imamura-fu@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | Fumio |
| Middle name | |
| Last name | Imamura |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of Thoracic Oncology
Zip code
5418567
Address
1-3-3 Nakamichi Higashinari-ku, Osaka 537-8511, Japan
TEL
0669721181
Homepage URL
imamura-fu@mc.pref.osaka.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Address
1-3-3 Nakamichi Higashinari-ku, Osaka 537-8511, Japan
Tel
+81669721181
imamura-fu@mc.pref.osaka.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
| 2011 | Year | 11 | Month | 24 | 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
38
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
| 2011 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2011 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Change of EGFR gene in plasma and its relevance to response to treatements
Management information
Registered date
| 2011 | Year | 11 | Month | 24 | Day |
Last modified on
| 2019 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008004
