UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060372 |
|---|---|
| Receipt number | R000069065 |
| Scientific Title | A Retrospective Observational Study on the Impact of Prior Dental Surgery on Treatment Outcomes for Gingival Squamous Cell Carcinoma |
| Date of disclosure of the study information | 2026/01/16 |
| Last modified on | 2026/01/15 18:34:59 |
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Basic information
Public title
A Retrospective Observational Study on the Impact of Prior Dental Surgery on Treatment Outcomes for Gingival Squamous Cell Carcinoma
Acronym
A Retrospective Observational Study on the Impact of Prior Dental Surgery on Treatment Outcomes for Gingival Squamous Cell Carcinoma
Scientific Title
A Retrospective Observational Study on the Impact of Prior Dental Surgery on Treatment Outcomes for Gingival Squamous Cell Carcinoma
Scientific Title:Acronym
A Retrospective Observational Study on the Impact of Prior Dental Surgery on Treatment Outcomes for Gingival Squamous Cell Carcinoma
Region
| Japan |
Condition
Condition
Gingival cancer
Classification by specialty
| Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the relationship between the presence or absence of prior dental surgery at the cancer site before initial treatment and the treatment course and prognosis in cases of gingival carcinoma.
Basic objectives2
Others
Basic objectives -Others
Differences in treatment outcomes (local recurrence, neck recurrence, and distant metastasis) based on prior dental surgery (time from initial diagnosis to event occurrence, with local recurrence, neck recurrence, and distant metastasis as events).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in survival rates based on prior dental surgery (time from initial visit to death, with death as the event)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases treated for gingival carcinoma at Nagasaki University Hospital's Department of Oral and Maxillofacial Surgery from June 1, 2008, to April 30, 2024.
Key exclusion criteria
Cases where medical records are insufficient and adequate information cannot be obtained, such as the presence or absence of prior dental surgery at the cancer site.
Target sample size
161
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Omori |
Organization
Nagasaki University
Division name
Department of Oral surgery
Zip code
851-2131
Address
1-7-1, sakamoto, nagasaki, Japan
TEL
0958197698
k-omori@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromasa |
| Middle name | |
| Last name | Fukushima |
Organization
Nagasaki University Hospital
Division name
Oral surgery
Zip code
852-8588
Address
1-7-1, sakamoto, nagasaki, Japan.
TEL
095-819-7698
Homepage URL
hirofuku922@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University
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
Nagasaki University
Address
1-7-1, sakamoto, nagasaki, Japan.
Tel
0958197698
k-omori@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
| 2026 | Year | 01 | Month | 16 | 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
| 2026 | Year | 01 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 01 | 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
| 2026 | Year | 01 | Month | 15 | Day |
Last modified on
| 2026 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069065
