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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009175
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010729

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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