UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027588 |
|---|---|
| Receipt number | R000031618 |
| Scientific Title | Prospective Cohort Study of Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Disease |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2018/07/17 09:31:12 |
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Basic information
Public title
Prospective Cohort Study of Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Disease
Acronym
Cryo cohort
Scientific Title
Prospective Cohort Study of Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Disease
Scientific Title:Acronym
Cryo cohort
Region
| Japan |
Condition
Condition
diffuse parenchymal lung disease
Classification by specialty
| Medicine in general | Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the impact and safety on diagnosis of transbronchial cryobiopsy for japanese diffuse parenchymal lung disease patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Impact of transbronchial cryobiopsy on diagnosis of diffuse parenchymal lung disease
Key secondary outcomes
Any adverse event and mortality
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients who received transbronchial cryobiopsy.
Key exclusion criteria
Patients who cannot acquire a agreement of participation in this cohort study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Ogura |
Organization
Kanagawa Cardiovascular and Respiratory Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
6-16-1 Tomioka-higashi, Kanazawa-ku, Yokohama, Japan
TEL
045-701-9581
ogura@kanagawa-junko.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Niwa |
Organization
Kanagawa Cardiovascular and Respiratory Medicine
Division name
Department of Respiratory Medicine
Zip code
Address
6-16-1 Tomioka-higashi, Kanazawa-ku, Yokohama, Japan
TEL
045-701-9581
Homepage URL
wanikko0714@gmail.com
Sponsor or person
Institute
Kanagawa Cardiovascular and Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Cardiovascular and Respiratory Medicine
Organization
Division
Category of Funding Organization
Local Government
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
| 2017 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 05 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is prospective observational cohort study.
Management information
Registered date
| 2017 | Year | 06 | Month | 01 | Day |
Last modified on
| 2018 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031618
