UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055554 |
|---|---|
| Receipt number | R000062492 |
| Scientific Title | Retrospective observational study of cancer excised with the clinical diagnosis of leukoplakia of the tongue |
| Date of disclosure of the study information | 2024/09/20 |
| Last modified on | 2024/09/20 09:30:46 |
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Basic information
Public title
Clinical study of squamous cell carcinoma excised with clinical diagnosis of leukoplakia of the tongue
Acronym
Clinical study of squamous cell carcinoma excised with clinical diagnosis of leukoplakia of the tongue
Scientific Title
Retrospective observational study of cancer excised with the clinical diagnosis of leukoplakia of the tongue
Scientific Title:Acronym
Retrospective observational study of cancer excised with the clinical diagnosis of leukoplakia of the tongue
Region
| Japan |
Condition
Condition
tongue cancer
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to establish evidence-based treatment by examining the appropriateness of additional treatment and survival rates based on pathologic margins and treatment outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Local or resional recurrence
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
Patients who visited the Department of Oral and Maxillofacial Surgery, Nagasaki University Hospital between June 1, 2008 and March 31, 2023, and underwent resection with a clinical diagnosis of tongue leukoplakia and a histopathological diagnosis of squamous cell carcinoma of the tongue.
Key exclusion criteria
Cases with insufficient information due to poor documentation in the medical information record.
Cases that are not squamous cell carcinoma.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomofumi |
| Middle name | |
| Last name | Naruse |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Oral and Maxillofacial Surgery
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki City
TEL
095-819-7698
naruse12@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomofumi |
| Middle name | |
| Last name | Naruse |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Department of Oral and Maxillofacial Surgery
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki City
TEL
095-819-7698
Homepage URL
naruse12@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
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
The Clinical Research Review Board in Nagasaki University
Address
1-7-1 Sakamoto, Nagasaki city
Tel
095-819-7229
gaibushikin@ml.nagasaki-u.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
| 2024 | Year | 09 | Month | 20 | 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
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 09 | Month | 20 | Day |
Last modified on
| 2024 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062492
