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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021711
Receipt No. R000025047
Scientific Title Exploratory study on somatic mutation detection using plasma DNA from patients with lung cancer
Date of disclosure of the study information 2016/03/31
Last modified on 2018/04/03

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Basic information
Public title Exploratory study on somatic mutation detection using plasma DNA from patients with lung cancer
Acronym Mutation detection using plasma DNA
Scientific Title Exploratory study on somatic mutation detection using plasma DNA from patients with lung cancer
Scientific Title:Acronym Mutation detection using plasma DNA
Region
Japan

Condition
Condition lung cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Investigation on usefulness of detection of somatic mutations in cancer-related genes using peripheral blood
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Feasibility
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 One blood draw (15 mL)
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Lung cancer patients who are pathologically or cytologically confirmed
Key exclusion criteria Not applicable
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Koh
Organization Wakayama Medical University
Division name Third Department of Internal Medicine
Zip code
Address 811-1 Kimiidera, Wakayama
TEL 073-441-0619
Email ykoh@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhiro Koh
Organization Wakayama Medical University
Division name Third Department of Internal Medicine
Zip code
Address 811-1 Kimiidera, Wakayama
TEL 073-441-0619
Homepage URL
Email ykoh@wakayama-med.ac.jp

Sponsor
Institute Third Department of Internal Medicine, Wakayama Medical University
Institute
Department

Funding Source
Organization Third Department of Internal Medicine, Wakayama Medical University
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
2016 Year 03 Month 31 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 No longer recruiting
Date of protocol fixation
2014 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 12 Month 04 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
2016 Year 03 Month 31 Day
Last modified on
2018 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025047

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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