UMIN-CTR Clinical Trial

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
Email	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
Email	yagi-to@mc.pref.osaka.jp

Sponsor
Institute	Department of Clinical Oncology, Osaka Medical Center for Cancer and Cardiovascular diseases
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014582

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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