UMIN-CTR Clinical Trial

Basic information
Public title	Analysis the relationship of carbon monoxide in exhaled breath and non-small cell lung cancer
Acronym	Analysis the relationship of carbon monoxide in exhaled breath and non-small cell lung cancer
Scientific Title	Analysis the relationship of carbon monoxide in exhaled breath and non-small cell lung cancer
Scientific Title:Acronym	Analysis the relationship of carbon monoxide in exhaled breath and non-small cell lung cancer
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Exhaled carbon monoxide concentration in non-smoking or former-smoking non-small cell lung cancer patients
Basic objectives2	Others
Basic objectives -Others	Exhaled carbon monoxide concentration
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Exhaled carbon monoxide concentration in non-smoking or former-smoking non-small cell lung cancer patients
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	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	Measurement of expiratory carbon monoxide
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	1) Patients diagnosed pathologically as non-small cell lung carcinoma 2) Non smoking or former-smoking patients 3) Non-passive smoker 4) Patients without coexistence of other respiratory diseases 5) Patients without active infectious disease 6) Patients who can measure breath carbon monoxide concentration 7) After receiving sufficient explanation for the participation of this study, patients who obtained document consent by the patient's free will with sufficient understanding
Key exclusion criteria	1) Patients who are not diagnosed pathologically as non-small cell lung carcinoma 2) Current smoker 3) Passive smoker 4) Patients with complications of other malignant diseases 5) Patients with complications of other respiratory diseases 6) Patients with Active infectious disease 7) Patients who are deemed inappropriate as research subjects by research staff
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Kiura Middle name Last name Katsuyuki
Organization	Okayama University Hospital
Division name	Department of Allergy and Respiratory Medicine
Zip code	700-8558
Address	2-5-1, Shikata cho, Kita Ku, Okayama city, Okayama prefecture
TEL	086-235-7227
Email	kkiura@md.okayama-u.ac.jp

Public contact
Name of contact person	1st name Kazuya Middle name Last name Nishii
Organization	Okayama University Hospital
Division name	Department of Allergy and Respiratory Medicine
Zip code	700-8558
Address	2-5-1, Shikata cho, Kita Ku, Okayama city, Okayama prefecture
TEL	086-235-7227
Homepage URL
Email	p98x94kg@s.okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

Funding Source
Organization	Okayama 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	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address	2-5-1 Shikatacho, Kitaku, Okayama 700-8558, Japan
Tel	086-235-6938
Email	mae6605@adm.okayama-u.ac.jp

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	2018 Year 05 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	Enrolling by invitation
Date of protocol fixation	2018 Year 02 Month 24 Day
Date of IRB	2018 Year 06 Month 22 Day
Anticipated trial start date	2018 Year 06 Month 22 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 02 Month 26 Day
Last modified on	2021 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035948