UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040365 |
|---|---|
| Receipt number | 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 | 2020/11/11 18:29:06 |
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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
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
t_standing_2106@yahoo.co.jp
Sponsor or person
Institute
Department of Oncology, Immunology and Surgery, Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
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
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 | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046059
