UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012460 |
|---|---|
| Receipt number | R000014582 |
| Scientific Title | The study for detecting EGFR and K-ras mutation in plasma of patinets with cancer |
| Date of disclosure of the study information | 2013/12/02 |
| Last modified on | 2013/12/02 15:55:57 |
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Basic information
Public title
The study for detecting EGFR and K-ras mutation in plasma of patinets with cancer
Acronym
The study for detecting EGFR and K-ras mutation in plasma of patinets with cancer
Scientific Title
The study for detecting EGFR and K-ras mutation in plasma of patinets with cancer
Scientific Title:Acronym
The study for detecting EGFR and K-ras mutation in plasma of patinets with cancer
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To examine the frequency of EGFR and K-ras mutation in plasma of patients with cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of EGFR and K-ras mutation in plasma of patients with cancer
Key secondary outcomes
False positive rate of EGFR in plasma
Concordance rate of K-ras mutation between tissue and plasma
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
blood examination
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
Patients with cancer other than lung cancer
Patients without curative treatment
Patients without any other cancer
Patients with written informed consent
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumio Imamura |
Organization
Osaka Medical Center for Cancer and Cardiovascular diseases
Division name
Clinical Oncology
Zip code
Address
1-3-3 Nakamichi Higasinari-ku, Osaka
TEL
06-6972-1181
imamura-fu@mc.pref.osaka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshinari Yagi |
Organization
Osaka Medical Center for Cancer and Cardiovascular diseases
Division name
Clinical Oncology
Zip code
Address
1-3-3 Nakamichi Higasinari-ku, Osaka
TEL
06-6972-1181
Homepage URL
yagi-to@mc.pref.osaka.jp
Sponsor or person
Institute
Department of Clinical Oncology, Osaka Medical Center for Cancer and Cardiovascular diseases
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
| 2013 | Year | 12 | Month | 02 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 02 | Day |
Last modified on
| 2013 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014582
| 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 |
