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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027588
Receipt No. 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

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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
Email 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
Email wanikko0714@gmail.com

Sponsor
Institute Kanagawa Cardiovascular and Respiratory Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031618

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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