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

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 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


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

Value
https://center6.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