UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006762 |
|---|---|
| Receipt number | R000008002 |
| Scientific Title | Detection of EGFR and K-ras gene mutations in serum of non-small cell lung cancer patients |
| Date of disclosure of the study information | 2011/11/24 |
| Last modified on | 2019/05/31 10:20:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Detection of EGFR and K-ras gene mutations in serum of non-small cell lung cancer patients
Acronym
Detection of EGFR and K-ras gene mutations in serum
Scientific Title
Detection of EGFR and K-ras gene mutations in serum of non-small cell lung cancer patients
Scientific Title:Acronym
Detection of EGFR and K-ras gene mutations in serum
Region
| Japan |
Condition
Condition
Adenocarcinoma of the lung
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Sensitivity ans specificity of detection with plasma of EGFR and L-ras gene mutation in non-small cell lung cancer
Basic objectives2
Others
Basic objectives -Others
Evaluation of relationship between EGFR and K-ras mutation
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Sensitivity and specificity of evaluation of EGFR and K-ras gene mutation with plasma
Key secondary outcomes
Correlation between EGFR and K-ras gene mutation evaluated with plasma
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
Treatment-naive patients with lung adenocarcinoma EGFR of which will be tested
Key exclusion criteria
Nothing
Target sample size
320
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
+81-6-6972-1181
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
+81-6-6972-1181
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
Self funding
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
0669721181
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
大阪府立成人病センター、大阪市立総合医療センター、大阪大学医学部
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
288
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 | 21 | Day |
Date of IRB
| 2011 | Year | 10 | Month | 09 | 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
Comparison of EGFR adn K-ras gene between plasma and tumors
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=R000008002
