UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003491 |
|---|---|
| Receipt number | R000004229 |
| Scientific Title | Analysis for interstitial fluid pressure of thymoma |
| Date of disclosure of the study information | 2010/04/20 |
| Last modified on | 2017/10/22 11:33:58 |
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Basic information
Public title
Analysis for interstitial fluid pressure of thymoma
Acronym
Interstitial fluid pressure of thymoma
Scientific Title
Analysis for interstitial fluid pressure of thymoma
Scientific Title:Acronym
Interstitial fluid pressure of thymoma
Region
| Japan |
Condition
Condition
thymoma
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine whether interstital fluid pressure of thymoma would be a novel prognostic factor for thymoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
To examine whether there is correlation between interstitial fluid pressure of thymoma and prognostic factor for thymoma reported previously
Key secondary outcomes
To examine whether there is correlation between interstitial fluid pressure of thymoma and diagnostic imaging for thymoma
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
From April 2010 to March 2013
To measure interstitail fluid pressure of thymoma during and after thymomectomy
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
Patient who have thymoma or mediastinal tumor thought to be thymoma, gave informed consent.
Key exclusion criteria
Patient who have thymoma or mediastinal tumor thought to be thymoma, did not give informed consent
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Mori |
Organization
Kumamoto university Hospital
Division name
Thoracic surgery
Zip code
Address
1-1-1 Honjo Kumamoto
TEL
096-373-5533
morimori@fc.kuh.kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Mori |
Organization
Kumamoto University Hospital
Division name
Thoracic Surgery
Zip code
Address
1-1-1 Honjo, Kumamoto
TEL
096-373-5533
Homepage URL
morimori@fc.kuh.kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Thoracic Surgery, Kumamoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
| 2010 | Year | 04 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | 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
| 2010 | Year | 04 | Month | 14 | Day |
Last modified on
| 2017 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004229
