UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042758 |
|---|---|
| Receipt number | R000048806 |
| Scientific Title | Preliminary prediction of recovery rate of bronchoalveolar lavage by injecting a small amount of saline; Pilot study |
| Date of disclosure of the study information | 2020/12/24 |
| Last modified on | 2021/04/17 11:29:14 |
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Basic information
Public title
Preliminary prediction of recovery rate of bronchoalveolar lavage by injecting a small amount of saline; Pilot study
Acronym
Prediction BAL
Scientific Title
Preliminary prediction of recovery rate of bronchoalveolar lavage by injecting a small amount of saline; Pilot study
Scientific Title:Acronym
Prediction BAL
Region
| Japan |
Condition
Condition
Diffuse lung disease
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine whether the good or bad saline recovery rate can be predicted in advance when the bronchoalveolar lavage procedure is performed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between the amount of BALF recovered after injection of 20 ml of saline and the amount of bronchoalveolar lavage fluid recovered after injection of 150 ml.
Key secondary outcomes
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Bronchoalveolar lavage
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) Consent for bronchoscopy has been obtained.
2) Have lung disease for which bronchoalveolar lavage is indicated.
3) Age at the time of consent is 20 years or older.
4) Written consent has been obtained from the individual regarding participation in the research.
Key exclusion criteria
1) Cases judged to be inappropriate by the attending physician / examination doctor.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takamasa |
| Middle name | |
| Last name | Hotta |
Organization
Shimane University
Division name
Department of internal medicine. Division of medical oncology & respiratory medicine
Zip code
6938501
Address
89-1 Enya-cho, Izumo, Shimane, 693-8501, Japan.
TEL
0853-20-2580
takamasa@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Hotta |
Organization
Shimane University
Division name
Department of internal medicine. Division of medical oncology & respiratory medicine
Zip code
6938501
Address
89-1 Enya-cho, Izumo, Shimane, 693-8501, Japan.
TEL
0853-20-2580
Homepage URL
takamasa@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University.Department of internal medicine. Division of medical oncology & respiratory medicine.
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
Shimane University, School of Medicine
Address
89-1 Enya-cho, Izumo, Shimane, 693-8501, Japan.
Tel
0853-20-2580
kenkyu@med.shimane-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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 24 | 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
10
Results
The correlation between the recovery amount of 20 ml of saline and the recovery amount of bronchoalveolar lavage fluid was evaluated by Spearman's rank correlation coefficient. The correlation coefficient was 0.3199, showing a weak correlation. Similarly, the correlation coefficients of 50 ml and 100 ml of physiological saline were 0.7414 (50 ml) and 0.9362 (100 ml), showing a strong correlation.
Results date posted
| 2021 | Year | 04 | Month | 17 | Day |
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
| 2020 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 28 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 17 | Day |
Date of closure to data entry
| 2021 | Year | 04 | Month | 17 | Day |
Date trial data considered complete
| 2021 | Year | 04 | Month | 17 | Day |
Date analysis concluded
| 2021 | Year | 04 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 15 | Day |
Last modified on
| 2021 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048806
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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