UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039618 |
|---|---|
| Receipt number | R000045186 |
| Scientific Title | The efficacy of cryobiopsy for peripheral pulmonary lesions |
| Date of disclosure of the study information | 2020/02/27 |
| Last modified on | 2020/02/27 15:11:38 |
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Basic information
Public title
The efficacy of cryobiopsy for peripheral pulmonary lesions
Acronym
The efficacy of cryobiopsy for peripheral pulmonary lesions
Scientific Title
The efficacy of cryobiopsy for peripheral pulmonary lesions
Scientific Title:Acronym
The efficacy of cryobiopsy for peripheral pulmonary lesions
Region
| Japan |
Condition
Condition
Peripheral pulmonary lesions
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To compare a diagnostic accuracy and pathological tissue information between EBUS-TBB and EBUS-TBCB
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy for EBUS-TBB and EBUS-TBCB
Key secondary outcomes
1)Concordance of pathological subtype and a degree of differentiation among TBB, TBCB and surgical materials in early stage LC.
2)Quantitative and qualitive validity of NGS analysis for TBCB sample in advanced LC.
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
1) A case for suspected lung tumor
2) Written informed consent
Key exclusion criteria
Other cases attending physician it is determined unsuitable for registration of the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Morikawa |
Organization
St. Marianna University School of Medicine
Division name
Division of Respiratory Diseases, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1 Sugao Miyamae-ku, Kawasaki
TEL
044-977-8111
mokke5454@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Morikawa |
Organization
St. Marianna University School of Medicine
Division name
Division of Respiratory Diseases, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1 Sugao Miyamae-ku, Kawasaki
TEL
044-977-8111
Homepage URL
mokke5454@yahoo.co.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
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
St. Marianna University School of Medicine
Address
2-16-1 Sugao Miyamae-ku, Kawasaki
Tel
044-977-8111
mokke5454@yahoo.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
to be registerd
Org. issuing International ID_1
St. Marianna University School of Medicine
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 | 02 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 02 | Month | 27 | Day |
Last modified on
| 2020 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045186
