UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014552 |
|---|---|
| Receipt number | R000016930 |
| Scientific Title | A phase II study of talc poudrage for patients with malignant pleural effusions |
| Date of disclosure of the study information | 2014/07/14 |
| Last modified on | 2019/08/08 16:18:44 |
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Basic information
Public title
A phase II study of talc poudrage for patients with malignant pleural effusions
Acronym
A phase II study of talc poudrage for patients with malignant pleural effusions
Scientific Title
A phase II study of talc poudrage for patients with malignant pleural effusions
Scientific Title:Acronym
A phase II study of talc poudrage for patients with malignant pleural effusions
Region
| Japan |
Condition
Condition
malignant pleural effusion
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of talc poudrage for malignant pleural effusion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Pleural effusion control rate 30 days after talc poudrage.
Key secondary outcomes
Pain, pyrexia, oxygen saturation, and flow rate of oxygen after talc poudrage.
Adverse effect.
Time to reccurence of pleural effusion.
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 with talc poudrage (4g).
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. Malignant pleural effusion confirmed by histopathology or cytology.
2. Symptomatic with malignant pleural effusion and needs intervention.
3. Relief of symptoms is expected with drainage of pleural effusion.
4. Life expectancy of 30 days or more.
5. ECOG PS is expected to be 0-2 after darainage of pleural effusion.
6. 20 years of age or older.
7. Written informed consent from patient is gained.
Key exclusion criteria
1. Hypersensitivity to talc.
2. Hypersensitivity to lidocaine hydrochrolide.
3. Severe infection.
4. Severe hypoxemia despite oxgen therapy.
5. Uncontrolled angina or heart failure.
6. Myocardical infarction within 30 days of consent.
7. Severe bleeding diathesis. INR > 2.0 or platelet <60000/mm3.
8. Severe pleural adhesion.
9. Indication for bilateral pleurodesis.
10. History of pleurodeis of affected side.
11. Preganant or during lactation. Patient who hopes to bear child, or who can not keep contraceptive maneuver.
12. Inappropriate to enter this trial judged by the physician in charge
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kenya |
| Middle name | |
| Last name | Yoshida |
Organization
Nishichita General Hospital
Division name
Department of Repiratory Medicine
Zip code
4778522
Address
Nakanoike3-1-1, Tokai-shi, Aichi-ken
TEL
0562-33-5500
kenyayoshida@minos.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Kenya |
| Middle name | |
| Last name | Yoshida |
Organization
Nishichita General Hospital
Division name
Department of Repiratory Medicine
Zip code
4778522
Address
Nakanoike3-1-1, Tokai-shi, Aichi-ken
TEL
0562-33-5500
Homepage URL
kenyayoshida@minos.ocn.ne.jp
Sponsor or person
Institute
Nishichita General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Nishichita General Hospital
Address
Nakanoike3-1-1, Tokai-shi, Aichi-ken
Tel
0562-33-5500
ngh@nishichita-hp.aichi.jp
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
公立西知多総合病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 14 | 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
7
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
| 2014 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 14 | Day |
Last modified on
| 2019 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016930
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| Registered date | File name |
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