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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040365
Receipt No. R000046059
Scientific Title The usefulness of fluorodeoxyglucose-positron emission tomography as a preoperative diagnostic tool for thymic epithelial tumors
Date of disclosure of the study information 2020/05/15
Last modified on 2020/05/11

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Basic information
Public title The usefulness of fluorodeoxyglucose-positron emission tomography as a preoperative diagnostic tool for thymic epithelial tumors
Acronym The usefulness of fluorodeoxyglucose-positron emission tomography for thymic epithelial tumors
Scientific Title The usefulness of fluorodeoxyglucose-positron emission tomography as a preoperative diagnostic tool for thymic epithelial tumors
Scientific Title:Acronym The usefulness of fluorodeoxyglucose-positron emission tomography for thymic epithelial tumors
Region
Japan

Condition
Condition Thymic epithelial tumors
Classification by specialty
Chest surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Investigation about the usefulness of 18F-FDG PET for the preoperative imaging diagnosis of thymic epithelial tumors (TETs) .
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The usefulness of 18F-fluorodeoxy glucose-positron emission tomography (18F-FDG PET) for predicting the malignant grade in TETs.
Key secondary outcomes The assessment of correlation between the SUVmax and TETs sizes.

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
44 years-old <=
Age-upper limit
67 years-old >=
Gender Male and Female
Key inclusion criteria Patients with TETs diagnosed and performed 18F-FDG PET from 2005 to 2018 at Toyota Memorial Hospital.
Key exclusion criteria None.
Target sample size 51

Research contact person
Name of lead principal investigator
1st name Tsutomu
Middle name
Last name Tatematsu
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Oncology, Immunology and Surgery
Zip code 4678601
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL 0528538231
Email t_standing_2106@yahoo.co.jp

Public contact
Name of contact person
1st name Tsutomu
Middle name
Last name Tatematsu
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Oncology, Immunology and Surgery
Zip code 4678601
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL 0528538231
Homepage URL
Email t_standing_2106@yahoo.co.jp

Sponsor
Institute Department of Oncology, Immunology and Surgery, Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization None
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 Department of Oncology, Immunology and Surgery, Nagoya City University Graduate School of Medical Sciences
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
Tel 0528538231
Email t_standing_2106@yahoo.co.jp

Secondary IDs
Secondary IDs YES
Study ID_1 R108
Org. issuing International ID_1 Toyota Memorial Hospital
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 05 Month 15 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 51
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
2019 Year 09 Month 01 Day
Date of IRB
2019 Year 10 Month 02 Day
Anticipated trial start date
2019 Year 10 Month 03 Day
Last follow-up date
2019 Year 10 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2020 Year 05 Month 11 Day
Last modified on
2020 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046059

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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