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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004434
Receipt No. R000005303
Scientific Title The efficacy of CT screening on early detection of lung cancer for patients with COPD
Date of disclosure of the study information 2010/11/01
Last modified on 2010/10/24

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Basic information
Public title The efficacy of CT screening on early detection of lung cancer for patients with COPD
Acronym Screening of lung cancer for COPD
Scientific Title The efficacy of CT screening on early detection of lung cancer for patients with COPD
Scientific Title:Acronym Screening of lung cancer for COPD
Region
Japan

Condition
Condition Chronic Obstructive Pulmonary disease
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Patients with COPD are enrolled and taken computed tomography every year for detecting eaely lung cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The rate of lung cancer detection
Key secondary outcomes Early detection of lung cancer

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 HRCT
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
0 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria COPD
Key exclusion criteria Past history of cancer within five years
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name YASUO SEKINE
Organization Tokyo Women's Medical University Yachiyo Medical Center
Division name Thoracic Surgery
Zip code
Address 477-96 Owada-Shinden, Yachiyo, Chiba, Japan
TEL 047-450-6000
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Chiba COPD Lung Cancer Screening
Division name Head Office
Zip code
Address
TEL
Homepage URL
Email ysekine@tymc.twmu.ac.jp

Sponsor
Institute Yasuo Sekine
Institute
Department

Funding Source
Organization Chiba Foundation for Health Promotion and Disease Prevention
Organization
Division
Category of Funding Organization Non profit foundation
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
2010 Year 11 Month 01 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
2010 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2014 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 10 Month 24 Day
Last modified on
2010 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005303

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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