UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001766 |
|---|---|
| Receipt number | R000002119 |
| Scientific Title | Narrow Band Imaging Applied to Pleuroscopy for the Assessment of Vascular Patterns of Pleura |
| Date of disclosure of the study information | 2009/03/11 |
| Last modified on | 2009/11/11 09:52:39 |
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Basic information
Public title
Narrow Band Imaging Applied to Pleuroscopy for the Assessment of Vascular Patterns of Pleura
Acronym
Narrow Band Imaging for Pleuroscopy
Scientific Title
Narrow Band Imaging Applied to Pleuroscopy for the Assessment of Vascular Patterns of Pleura
Scientific Title:Acronym
Narrow Band Imaging for Pleuroscopy
Region
| Japan |
Condition
Condition
pleural effusion of unknown etiology
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of NBI applied to pleuroscopy for detecting malignant lesions by assessing vascular patterns of pleura.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
diagnostic yield.
Key secondary outcomes
Whether NBI can distinguish malignant pleural lesions from benign lesions.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Endoscopic images obtained by NBI.
Interventions/Control_2
Endoscopic images obtained by white light.
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
Over 20 years of age, and ability to understand and sign informed consent forms.
Key exclusion criteria
Inability to tolerate pleuroscopy under local anesthesia, such as Eastern Cooperative Oncology Group (ECOG) PS 4, inadequate lung function parameters (PaCO2>55 mmHg, PaO2<60 mmHg), uncontrolled bleeding tendency, and severe heart failure.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Teruomi Miyazawa |
Organization
St Marianna University School of Medicine
Division name
Division of Respiratory and Infectious Diseases, Department of Internal Medicine
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Japan 216-8511
TEL
044-977-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuko Ishida |
Organization
St Marianna University School of Medicine
Division name
Division of Respiratory and Infectious Diseases, Department of Internal Medicine
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Japan 216-8511
TEL
044-977-8111
Homepage URL
atsuko-i@do3.enjoy.ne.jp
Sponsor or person
Institute
St Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2009 | Year | 03 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2006 | Year | 05 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 03 | Month | 11 | Day |
Last modified on
| 2009 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002119
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
