UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Detection of histological type and genetic mutation in lung cancer using ion mobility spectrometry
Title of the study (Brief title)	Diagnosis of lung cancer using IMS
Region	Japan

Condition
Condition	To investigate if IMS can diagnosis histological type and genetic mutation using volatile organic compounds (VOCs) in patients with lung cancer.
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To identify specific VOC patterns in patients with lung cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To investigate if IMS can diagnosis histological type and genetic mutation using volatile organic compounds (VOCs) in patients with lung cancer.
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	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Lung cancer: To collect 10ml of exhaled air using BioScout.
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) No treatment of lung cancer 2) To agree to give informed consent
Key exclusion criteria	1) To refuse to give informed consent 2) Lung cancer of unknown histological type 3) Patients with no diagnosis of lung cancer 4) Patients who are pregnant, possibly pregnant, or lactating. 5) Patients with renal failure. (serum creatinine > 2.0 mg/dL, BUN > 30mg/dl) 6) AST or ALT > 100IU 7) Patients with severe diabetes, hyperlipidemia or hyperuricemia 8) Patients who are judged inappropriate by the doctor in charge.
Target sample size	30

Research contact person
Name of lead principal investigator	Teruomi Miyazawa
Organization	St. Marianna University School of Medicine Division of Respiratory and Infectious Diseases, Department of Internal Medicine
Division name	Division of Respiratory and Infectious Diseases, Department of Internal Medicine
Address	2-16-1 Sugao Miyamae-ku, Kawasaki, Kanagawa, Japan 216-8511
TEL	044-977-8111
Email

Public contact
Name of contact person	Hiroshi Handa
Organization	St. Marianna University School of Medicine
Division name	Division of Respiratory and Infectious Diseases, Department of Internal Medicine
Address	2-16-1 Sugao Miyamae-ku, Kawasaki, Kanagawa, Japan 216-8511
TEL	044-977-8111
Homepage URL
Email

Sponsor
Institute	St. Marianna University School of Medicine Division of Respiratory and Infectious Diseases, Department of Internal Medicine
Institute
Department

Funding Source
Organization	St. Marianna University School of Medicine Division of Respiratory and Infectious Diseases, Department of Internal Medicine
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	2012 Year 07 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 26 Day
Anticipated trial start date	2012 Year 07 Month 01 Day
Last follow-up date	2014 Year 05 Month 01 Day
Date of closure to data entry	2014 Year 05 Month 01 Day
Date trial data considered complete	2014 Year 05 Month 01 Day
Date analysis concluded	2014 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 07 Month 03 Day
Last modified on	2018 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009737