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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006696
Receipt No. R000007551
Scientific Title Ion Mobility Spectrometry in healthy and respiratory disease subjects
Date of disclosure of the study information 2011/11/09
Last modified on 2018/07/30

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Basic information
Public title Ion Mobility Spectrometry in healthy and respiratory disease subjects
Acronym IMS in healthy and respiratory disease subjects
Scientific Title Ion Mobility Spectrometry in healthy and respiratory disease subjects
Scientific Title:Acronym IMS in healthy and respiratory disease subjects
Region
Japan

Condition
Condition Healthy subjects and patients with respiratory disease
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To identify VOC patterns in healthy subjects.
To identify VOC patterns in patients with respiratory disease including lung cancer, bronchial asthma, COPD, infectious diseases, respiratory involvement in systemic disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To investigate if IMS can detect and discriminate between volatile organic compounds (VOCs) in patients with respiratory disease including lung cancer, bronchial asthma, COPD, infectious diseases and airway involvement in systemic disease.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 6
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 In healthy subjects:
To collect 10ml of exhaled air using BioScout.
Interventions/Control_2 Lung cancer:
To collect 10ml of exhaled air using BioScout.
Interventions/Control_3 Bronchial asthma:
To collect 10ml of exhaled air using BioScout.
Interventions/Control_4 COPD:
To collect 10ml of exhaled air using BioScout.
Interventions/Control_5 Respiratory infectious disease:
To collect 10ml of exhaled air using BioScout.
Interventions/Control_6 Airway involvement in systemic disease:
To collect 10ml of exhaled air using BioScout.
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 Patients with expiratory disease
a) Lung Cancer: adenocarcinoma, squamous cell carcinoma, small cell carcinoma, large cell carcinoma
b) Bronchial asthma: step I to IV
c) COPD stage I to IV
d) Respiratory infection: pneumonia, pleuritis, pyothorax
e) Airway abnormality in systemic disease: sarcoidosis, relapsing polychondritis, wegener granulomatosis
Key exclusion criteria 1) To refuse giving informed consent
2) Lung cancer of unknown histological type
3) Exacerbation within the last 3 months for bronchial asthma
4) Exacerbation within the last 3 months for COPD
5) Unknown bacterias
6) Patients who are pregnant, possibly pregnant, or lactating.
7) Patients with renal failure. (serum creatinine > 2.0 mg/dL, BUN > 30mg/dl)
8) AST or ALT > 100IU
9) Patients with severe diabetes, hyperlipidemia or hyperuricemia
10) Patients who are judged inappropriate by the doctor in charge.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Teruomi Miyazawa
Organization St. Marianna University School of Medicine
Division name 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 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
2011 Year 11 Month 09 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
1.Lung Cancer
A decision tree algorithm could separate patients with lung cancer including adenocarcinoma, squamous cell carcinoma and small cell carcinoma. One hundred-fifteen separated volatile organic compound (VOC) peaks were analyzed. Peak-2 noted as n-Dodecane using the IMS database was able to separate values with a sensitivity of 70.0% and a specificity of 89.7%. Incorporating a decision tree algorithm starting with n-Dodecane, a sensitivity of 76% and specificity of 100% was achieved. Comparing VOC peaks between adenocarcinoma and healthy subjects, n-Dodecane was able to separate values with a sensitivity of 81.3% and a specificity of 89.7%. Fourteen patients positive for EGFR mutation displayed a significantly higher n-Dodecane than for the 14 patients negative for EGFR (p<0.01), with a sensitivity of 85.7% and a specificity of 78.6%.

2. Relapsing polycondritis
A total of 88 VOC peaks in both RP patients and healthy volunteers were detected using Visual Now 2.2. 5 VOC peaks were significantly higher in the exhaled breath samples of RP patients compared to healthy subjects (p<0.001). P14 and P26a were noted as cyclohexanone and 1,2-Butandiol using the IMS database. In addition, P14 and P26a were able to separate values with a sensitivity of 80%, 60% and a specificity of 89.7%, 100% in RP patients, respectively. 

3. Infection: Stent-related Biofilm Formation
Bacteriologic culture from the removed silicone stents showed Pseudomonas aeruginosa biofilm formation
in 4 of the 6 patients.12 peaks were identified. Five of the 12 peaks differed significantly in signal intensity after removal of the initial stent. Comparison against an IMS database identified the following: peak no. 22 (P22), unknown (p<0.05); P23, limonene (p<0.05); P24: 2,2,4,6,6-pentaheptylmethane (p<0.05); P31, 1-octanol (p<0.05); and P35: phenylacetaldehyde (p<0.05).
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
2011 Year 02 Month 07 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 07 Day
Last follow-up date
2013 Year 01 Month 14 Day
Date of closure to data entry
2013 Year 01 Month 14 Day
Date trial data considered complete
2013 Year 01 Month 14 Day
Date analysis concluded
2014 Year 05 Month 22 Day

Other
Other related information

Management information
Registered date
2011 Year 11 Month 09 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=R000007551

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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