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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039065
Receipt No. R000044554
Scientific Title An exploratory study for examining genomic profile in thymic epithelial tumors
Date of disclosure of the study information 2020/01/07
Last modified on 2020/01/07

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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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