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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011968
Receipt No. R000012505
Scientific Title Ion mobility spectrometry measurements before and after treatment of lung cancer
Date of disclosure of the study information 2013/10/06
Last modified on 2013/10/06

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Basic information
Public title Ion mobility spectrometry measurements before and after treatment of lung cancer
Acronym IMS before and after treatment of lung cancer
Scientific Title Ion mobility spectrometry measurements before and after treatment of lung cancer
Scientific Title:Acronym IMS before and after treatment of lung cancer
Region
Japan

Condition
Condition Patients that will undergo lung cancer surgery, chemotherapy, radiation therapy and chemoradiation therapy
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess VOC levels in exhaled breath before and after treatment in patients with lung cancer.
Identification of VOC peaks for specific lung cancers.
Identification of treatment outcomes.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To observe if VOC peaks specific to lung cancer show changes after treatment.
Key secondary outcomes To evaluate VOC peak changes for different treatments; chemotherapy, radiation therapy and chemoradiation therapy.
To measure VOC peaks for the affected and healthy side of the lungs during single-sided ventilation.

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) patients 20 years of age or over with lung cancer.
2) Agree to give informed consent
Key exclusion criteria 1) Refuse to give informed consent
2) Patients who are pregnant, possibly pregnant, or lactating.
3) Patients with renal failure. (serum creatinine > 2.0 mg/dL, BUN > 30mg/dl)
4) AST or ALT > 100IU
5) Patients with severe diabetes, hyperlipidemia or hyperuricemia
6) Patients who are judged inappropriate by the doctor in charge.
Target sample size 100

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 m2okamoto@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mariko Okamoto
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 m2okamoto@marianna-u.ac.jp

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
2013 Year 10 Month 06 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 Open public recruiting
Date of protocol fixation
2013 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 10 Month 06 Day
Last modified on
2013 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012505

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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