UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009175 |
|---|---|
| Receipt number | R000010729 |
| Scientific Title | Talc pleurodesis for malignant pleural effusions. |
| Date of disclosure of the study information | 2012/10/24 |
| Last modified on | 2013/04/23 09:54:47 |
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Basic information
Public title
Talc pleurodesis for malignant pleural effusions.
Acronym
Talc pleurodesis.
Scientific Title
Talc pleurodesis for malignant pleural effusions.
Scientific Title:Acronym
Talc pleurodesis.
Region
| Japan |
Condition
Condition
malignant pleural effusion
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of talc for Japanese patients as a sclerosing agent to manage malignant pleural effusions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy. We evaluate at 30, 90, and 180 days after talc pleurodesis by chest radiography.
Key secondary outcomes
Safety. We evaluated any complications requiring additional treatment or procedures within 30 days after talc pleurodesis.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
pleurodesis by intrapleural administration of 4 g of sterile talc.
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
having uncontrolled and symptomatic pleural effusion, having proved to have malignant cells in pleural effusion by cytology or malignancies in pleural biopsy, and the ability to understand and sign informed consent forms.
Key exclusion criteria
having insufficient expansion of the lung after pleural fluid drainage (having trapped lung), inadequate lung function parameters, 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
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
St. Marianna University School of Medicine
Division name
Division of Respiratory and Infectious Diseases, Department of Internal Medicine
Zip code
Address
TEL
044-977-8111
Homepage URL
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
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
| 2012 | Year | 10 | Month | 24 | 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
Talc is considered to be acceptable in both efficacy and safety as sclerosing agent for pleurodesis also in Japanese patients.
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
| 2005 | Year | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 23 | Day |
Last modified on
| 2013 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010729
