UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Concomitant incidence of lung cancer in undiagnosed or unrecognized COPD patients
Title of the study (Brief title)	Concomitant incidence of lung cancer in undiagnosed or unrecognized COPD patients
Region	Japan

Condition
Condition	chronic obstructive pulmonary disease, lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the associaiton of airflow obstruction on spirometry with newly developed lung cancer in general healthy persons,to further exmine the pathological classicifaton of newly develped lung cancer in non-COPD and COPD patinets
Basic objectives2	Others
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	The freqency of COPD patients in healthy persosns, who underwent health checkup The incidence of newly develped lung cancer in COPD patients and non-COPD subjects
Key secondary outcomes	pathological classicifaton of newly develped lung cancer in non-COPD and COPD patinets

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Persons, who underwent health checkup in Japanese health checkup facilities These psrosons provide written, informed consent
Key exclusion criteria	(1)Coexistence of other major pulmonary diseases such as asthma, bronchiectasis, pulmonary fibrosis, tuberculosis, and pulmonary cancer diagnosed by imaging modalities and/or laboratory findings. (2)patients with cancers (3)patients with other serious complocations (4) Those who are considered as inappropriate subjects for any reasons.
Target sample size	10000

Research contact person
Name of lead principal investigator	Shinji Teramoto
Organization	Hitachinaka General Hospital
Division name	Department of pulmonary medicine
Address	20-1 Ishikawa-cho, Hitachinaka-shi, Ibaraki,Japan 312-0057
TEL	029-354-5111
Email	shinjit-tky@umin.ac.jp

Public contact
Name of contact person	Shinji Teramoto
Organization	Hitachinaka General Hospital
Division name	Department of pulmonary medicine
Address	20-1 Ishikawa-cho, Hitachinaka-shi, Ibaraki,Japan 312-0057
TEL	029-354-5111
Homepage URL
Email	shinjit-tky@umin.ac.jp

Sponsor
Institute	Hitachinaka Gneral Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Hitachinaka Gneral Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 30 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2012 Year 04 Month 01 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2018 Year 05 Month 05 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We investigate persons, who underwent health checkup from 2012 to 2018 in our and related health checkup facilities. We perform spirometry and chest X radiograph examination. The lung cancer suspected patients are further examined using Chest CT and transbronchoscopic lung biopsy. Lung cancer is determined by its pathology.

Management information
Registered date	2016 Year 03 Month 30 Day
Last modified on	2016 Year 04 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000025023