UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039065 |
|---|---|
| Receipt number | 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 00:46:00 |
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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
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
mimatsuo-ngs@umin.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044554
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
