UMIN-CTR Clinical Trial

Basic information
Public title	An exploratory study for examining genomic profile in thymic epithelial tumors
Acronym	An exploratory study for examining genomic profile in thymic epithelial tumors
Scientific Title	An exploratory study for examining genomic profile in thymic epithelial tumors
Scientific Title:Acronym	An exploratory study for examining genomic profile in thymic epithelial tumors
Region	Japan

Condition
Condition	thymic epithelial tumors
Classification by specialty	Medicine in general Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To examine the genomic profile of thymic epithelial tumors
Basic objectives2	Others
Basic objectives -Others	To examine the genomic profile of thymic epithelial tumors and the potential therapeutic targets
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Identification of the causative gene
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Thymic epithelial tumor patients diagnosed and treated
Key exclusion criteria	1. no consent for this study before the operation 2. A case with a diagnosis other than thymic epithelial tumor after surgery
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Yamaguchi
Organization	Nagasaki University Hospital
Division name	Second Department of Internal Medicine
Zip code	852-8501
Address	1-7-1 Sakamoto, Nagasaki city, Nagasaki, Japan
TEL	095-819-7273
Email	mimatsuo-ngs@umin.ac.jp

Public contact
Name of contact person	1st name Midori Middle name Last name Shimada
Organization	Sasebo City General Hospital
Division name	Respiratory Medicine
Zip code	857-8511
Address	9-3 Hirase-cho, Sasebo, Nagasaki, Japan
TEL	0956-24-1515
Homepage URL
Email	mimatsuo-ngs@umin.ac.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

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	Nagasaki University Hospital
Address	1-7-1 Sakamoto, Nagasaki city, Nagasaki, Japan
Tel	095-819-7273
Email	mimatsuo-ngs@umin.ac.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

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 07 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	32
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	2008 Year 01 Month 01 Day
Date of IRB	2013 Year 06 Month 01 Day
Anticipated trial start date	2013 Year 06 Month 01 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Review the recurrence, treatment, and prognosis of cases

Management information
Registered date	2020 Year 01 Month 07 Day
Last modified on	2020 Year 01 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044554

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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