UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054979 |
|---|---|
| Receipt number | R000062635 |
| Scientific Title | Multicenter prospective observational study assessing diagnostic value of microparticles involved in human exhaled breath |
| Date of disclosure of the study information | 2024/07/18 |
| Last modified on | 2024/07/16 18:30:09 |
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Basic information
Public title
Study on Diagnostic Value of Microparticles in Exhaled Breath
Acronym
MICROBREATH study
Scientific Title
Multicenter prospective observational study assessing diagnostic value of microparticles involved in human exhaled breath
Scientific Title:Acronym
MICROBREATH study
Region
| Japan |
Condition
Condition
Patients with various pulmonary diseases with definitive diagnosis using bronchoscopy
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
In patients with various lung diseases who are definitively diagnosed by bronchoscopy, we will collect exhaled breath condensate and evaluate the diagnostic accuracy of the non-invasive methods to diagnose lung disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Prediction accuracy of lung disease diagnosis by nano-particle analysis of exhaled breath condensate.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Adults aged 20 years or older who underwent respiratory endoscopy at the study center for the diagnosis of various lung diseases, including lung cancer, diffuse lung disease, chronic obstructive lung disease, asthma, and lung infection. A control group of healthy subjects who understand the purpose of the study will also be selected.
Key exclusion criteria
Cases in which breath collection is difficult due to the following conditions:
Poor general condition, including consciousness, circulation, and respiration.
Lack of cooperation in breath collection.
Presence of dyspnea, unable to endure breath collection through the circuit for more than 5 minutes.
Postoperative deformities of the face and oral cavity, or conditions such as tracheostomy, making breath collection through a mouthpiece impossible.
Any other conditions deemed inappropriate for breath collection by the attending physician.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Sakamoto |
Organization
Nagoya university
Division name
Department of Respiratory Medicine
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2167
sakamoto.koji.w5@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Sato |
Organization
Nagoya university
Division name
Department of Respiratory Medicine
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
TEL
052-744-2167
Homepage URL
satotomo.1005.90@gmail.com
Sponsor or person
Institute
Nagoya university
Institute
Department
Personal name
Sakamoto Koji
Funding Source
Organization
Advanced Research and Development Programs for Medical Innovation
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Hospital Clinical Trial Review Board (IRB)
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan 466-8560
Tel
052-744-1956
ack-tiken@med.nagoya-u.ac.jp
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
名古屋大学医学部附属病院(愛知県)、藤田医科大学病院（愛知県）、公立陶生病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non-invasive collection of exhaled breath condensate will be performed in patients undergoing bronchoscopy for the diagnosis of lung diseases. We will evaluate the accuracy of lung disease diagnosis by analyzing the particles in the exhaled breath condensate.
Management information
Registered date
| 2024 | Year | 07 | Month | 16 | Day |
Last modified on
| 2024 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062635
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