UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis for interstitial fluid pressure of thymoma
Title of the study (Brief title)	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	Takeshi Mori
Organization	Kumamoto university Hospital
Division name	Thoracic surgery
Address	1-1-1 Honjo Kumamoto
TEL	096-373-5533
Email	morimori@fc.kuh.kumamoto-u.ac.jp

Public contact
Name of contact person	Takeshi Mori
Organization	Kumamoto University Hospital
Division name	Thoracic Surgery
Address	1-1-1 Honjo, Kumamoto
TEL	096-373-5533
Homepage URL
Email	morimori@fc.kuh.kumamoto-u.ac.jp

Sponsor
Institute	Department of Thoracic Surgery, Kumamoto University Hospital
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2010 Year 03 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004229