UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006696 |
|---|---|
| Receipt number | 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 11:48:29 |
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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
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
Sponsor or person
Institute
St. Marianna University School of Medicine
Division of Respiratory and Infectious Diseases, Department of Internal Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007551
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