UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004434 |
|---|---|
| Receipt number | 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 12:03:03 |
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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
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
ysekine@tymc.twmu.ac.jp
Sponsor or person
Institute
Yasuo Sekine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005303
