UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024170 |
|---|---|
| Receipt number | R000027829 |
| Scientific Title | A prospective observational study: the utility of flex-rigid pleuroscopy for malignant pleural disease |
| Date of disclosure of the study information | 2016/09/27 |
| Last modified on | 2016/09/26 17:55:18 |
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Basic information
Public title
A prospective observational study: the utility of flex-rigid pleuroscopy for malignant pleural disease
Acronym
Pleuroscopy prospective observational study
Scientific Title
A prospective observational study: the utility of flex-rigid pleuroscopy for malignant pleural disease
Scientific Title:Acronym
Pleuroscopy prospective observational study
Region
| Japan |
Condition
Condition
malignant pleural disease
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of flex-rigid pleuroscopy for malignant pleural disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
diagnostic yield
Key secondary outcomes
1) safety
2) feasibility of molecular analysis
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Cases that is suspected to have pleural malignant disease by computed tomography (CT)
2) Cases that is required re-biopsy and tissue specimen for the recurrence of pleural malignant disease
3) Obtained comprehensive agreement for study
Key exclusion criteria
1) without CT before pleuroscopy
2) with severe pleural adhesions
3) severe respiratory failure of the contralateral lung
4) cases that can not quietly lie
5) SpO2 less than 90%
6) uncontrolled condition such as angina, myocardial infraction, severe bronchial asthmna, active lung infection, heart failure, bleeding tendency, and so on
7) during pregnancy
8) anticoagulants or antiplatelet agents can not be stopped for 3 days or more
9) difficult to get agreement by the document
10) other inappropriate reasons
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Nakai |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
Address
5-1-1, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
tnakai@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Nakai |
Organization
National Cancer Center Hospital
Division name
Endoscopy Division
Zip code
Address
5-1-1, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
tnakai@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
The National Cancer Center Research and Development Fund
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
| 2016 | Year | 09 | 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
| 2016 | Year | 09 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the efficacy of flex-rigid pleuroscopy for malignant pleural disease
Management information
Registered date
| 2016 | Year | 09 | Month | 26 | Day |
Last modified on
| 2016 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027829
