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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008328
Receipt No. R000009737
Scientific Title Detection of histological type and genetic mutation in lung cancer using ion mobility spectrometry
Date of disclosure of the study information 2012/07/03
Last modified on 2018/07/30

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Basic information
Public title Detection of histological type and genetic mutation in lung cancer using ion mobility spectrometry
Acronym Diagnosis of lung cancer using IMS
Scientific Title Detection of histological type and genetic mutation in lung cancer using ion mobility spectrometry
Scientific Title:Acronym 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
1st name
Middle name
Last name 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
Zip code
Address 2-16-1 Sugao Miyamae-ku, Kawasaki, Kanagawa, Japan 216-8511
TEL 044-977-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Handa
Organization St. Marianna University School of Medicine
Division name Division of Respiratory and Infectious Diseases, Department of Internal Medicine
Zip code
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)

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
2012 Year 07 Month 03 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2012 Year 06 Month 26 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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