UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033284 |
|---|---|
| Receipt number | R000037791 |
| Scientific Title | Multicenter prospective trial of transbronchial cryobiopsy to evaluate its safety and utility |
| Date of disclosure of the study information | 2018/07/04 |
| Last modified on | 2019/12/27 20:51:38 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Multicenter prospective trial of transbronchial cryobiopsy to evaluate its safety and utility
Acronym
Multicenter prospective trial of transbronchial cryobiopsy
Scientific Title
Multicenter prospective trial of transbronchial cryobiopsy to evaluate its safety and utility
Scientific Title:Acronym
Multicenter prospective trial of transbronchial cryobiopsy
Region
| Japan |
Condition
Condition
Diffuse interstitial lung disease (interstitial pneumonia, idiopathic pulmonary fibrosis, chronic hypersensitivity pneumonitis, sarcoidosis), malignant tumor (lung cancer, mesothelioma, metastatic lung carcinoma), respiratory infectious disease (tuberculosis, nontuberculosis mycobacterial infection, pulmonary aspergillosis), other diseases
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and utility of transbronchial cryobiopsy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Provability of moderate to severe adverse events
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Respiraotry disease
Key exclusion criteria
1) Patients are excluded if they have past history of severe allergy to sedative drugs (lidocaine, midazolam, pethidine and so on)
2) Patients are excluded if they are suspected to have tendency of bleeding from cryobiopsy lesion because of aneurysm of bronchoartery and lung metastasis of renal cell carcinoma and so on.
3) Patients are excluded if they can't stop anticoagulation therapy.
4) Patients are excluded if they have uncontrolled comlication such as unstable angina, acute myocardial infarction, heart failure and severe bronchial asthma attack.
5) Patients are excluded if they are pregnant.
6) Patients are excluded if their doctor decide not to include.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Inomata |
Organization
Japanese Red Cross Medical Center
Division name
Department of Pulmonary Medicine
Zip code
Address
4-1-22 Hiroo Shibuya-ku Tokyo
TEL
03-3400-1311
inomataminoru@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minoru Inomata |
Organization
Japanese Red Cross Medical Center
Division name
Department of Pulmonary Medicine
Zip code
Address
4-1-22 Hiroo Shibuya-ku Tokyo
TEL
03-3400-1311
Homepage URL
inomataminoru@nms.ac.jp
Sponsor or person
Institute
Japanese Red Cross Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japanese Red Cross Medical Center
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 04 | 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 | 07 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 16 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 27 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 27 | Day |
Other
Other related information
To evaluate safety and utility of transbronchial cryobiopsy
Management information
Registered date
| 2018 | Year | 07 | Month | 04 | Day |
Last modified on
| 2019 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037791
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
