UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043587 |
|---|---|
| Receipt number | R000049702 |
| Scientific Title | Analysis of BAL amylase, pepsin and lipase a biomarker of aspiration pneumonia |
| Date of disclosure of the study information | 2021/03/14 |
| Last modified on | 2022/10/05 19:07:15 |
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Basic information
Public title
Analysis of BAL amylase, pepsin and lipase a biomarker of aspiration pneumonia
Acronym
Investigation of a biomarker for aspiration pneumonia
Scientific Title
Analysis of BAL amylase, pepsin and lipase a biomarker of aspiration pneumonia
Scientific Title:Acronym
Investigation of a biomarker for aspiration pneumonia
Region
| Japan |
Condition
Condition
aspiration pneumonia
Classification by specialty
| Pneumology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
BAL amylase or BAL pepsin levels contributes aspiration pneumonia as biomarkers.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BAL amylase or pepsin level is higher than other respiratory diseases.
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
adult patients undergoing a clinically indicated bronchoscopy at Aizu Medical Center whom consent was obtained
Key exclusion criteria
Patients who did not consent
Target sample size
336
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Suzuki |
Organization
Aizu Medical Center, Fukushima Medical University
Division name
Infectious Disease and Pulmonary Medicine
Zip code
9693492
Address
21-2, Maeda, Tanisawa, Kawahigashimachi, Aizuwakamatsu
TEL
0242752100
suzukito@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Suzuki |
Organization
Aizu Medical Center, Fukushima Medical University
Division name
Infectious Disease and Pulmonary Medicine
Zip code
9693492
Address
21-2, Maeda, Tanisawa, Kawahigashimachi, Aizuwakamatsu
TEL
0242752100
Homepage URL
suzukito@fmu.ac.jp
Sponsor or person
Institute
Aizu Medical Center, Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Aizu Medical Center, Fukushima Medical University
Address
21-2, Maeda, Tanisawa, Kawahigashimachi, Aizuwakamatsu
Tel
0242752100
suzukito@fmu.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 14 | Day |
Related information
URL releasing protocol
https://doi.org/10.1016/j.pulmoe.2022.04.003
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.pulmoe.2022.04.003
Number of participants that the trial has enrolled
327
Results
48 of aspiration pneumonia of the 327 participants. Median BAL amylase and pepsin levels in this group were 702.0 U/L and 12.7 ng/ml, respectively, significantly higher than in non-aspiration pneumonia patients. BAL amylase>204 U/L had 77.1% sensitivity and 84.2% specificity as a diagnostic index, and the AUC of ROC was 0.859(95%CI 0.803-0.915). Similarly, BAL pepsin levels of>7.45 ng/ml had 87.2% sensitivity and 59.9% specificity for identifying aspiration, and the AUC of ROC was 0.757(95%CI 0.688-0.826).
Results date posted
| 2022 | Year | 10 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We conducted a cross-sectional study of adult patients undergoing clinically-indicated bronchoscopy at Aizu Medical Center from June 2014 to May 2020. This study included 327 consenting patients.
Participant flow
Forty-eight cases among 327 were confirmed by three experienced pulmonologists and two experienced radiologists based on adult pneumonia guidelines by the JRS.
Adverse events
NA
Outcome measures
BAL-amylase level
BAL-pepsin level
risk factor of aspiration
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 11 | Month | 30 | Day |
Other
Other related information
an observation study
a cross-sectional study
adult patients undergoing a clinically indicated bronchoscopy at Aizu Medical Center were confirmed whom consent was obtained
Management information
Registered date
| 2021 | Year | 03 | Month | 11 | Day |
Last modified on
| 2022 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049702
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