UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032880 |
|---|---|
| Receipt number | R000037454 |
| Scientific Title | Retrospective study of factors in diagnosis by means of bronchoscopy |
| Date of disclosure of the study information | 2018/07/15 |
| Last modified on | 2018/06/14 08:43:17 |
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Basic information
Public title
Retrospective study of factors in diagnosis by means of bronchoscopy
Acronym
Retrospective study of factors in diagnosis by means of bronchoscopy
Scientific Title
Retrospective study of factors in diagnosis by means of bronchoscopy
Scientific Title:Acronym
Retrospective study of factors in diagnosis by means of bronchoscopy
Region
| Japan |
Condition
Condition
respiratory disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The safety and diagnostic yield of transbronchial cryobiopsy in respiratory disease
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
complications
Key secondary outcomes
procedure time, diagnostic yield
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
The patients who were performed transbronchial cryobiopsy were collected consecutively in the Japanese red cross medical center from November 2017 to May 2018.
The attending physician determined whether or not the cryobiopsy is necessary for diagnosis.
Key exclusion criteria
Patients who are not tolerable for bronchoscopy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takehiro Izumo |
Organization
Japanese Red Cross Medical Center
Division name
Respiratory Medicine
Zip code
Address
4-1-22 Hiroo Shibuya-ku Tokyo 150-8935, Japan
TEL
+81-3-3400-1311
drtake1118@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoyuki Kuse |
Organization
Japanese Red Cross Medical Center
Division name
Respiratory Medicine
Zip code
Address
4-1-22 Hiroo Shibuya-ku Tokyo 150-8935, Japan
TEL
+81-3-3400-1311
Homepage URL
nao-k-u@nms.ac.jp
Sponsor or person
Institute
Japanese Red Cross Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
日本赤十字社医療センター （東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 15 | 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
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We conducted a retrospective review from November 2017 to May 2018.
Management information
Registered date
| 2018 | Year | 06 | Month | 05 | Day |
Last modified on
| 2018 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037454
