UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050811 |
|---|---|
| Receipt number | R000057901 |
| Scientific Title | A retrospective study on other risk features and postoperative adjuvant therapy in oral squamous cell carcinoma |
| Date of disclosure of the study information | 2023/04/11 |
| Last modified on | 2023/04/11 00:05:03 |
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Basic information
Public title
A retrospective study on other risk features and postoperative adjuvant therapy in oral squamous cell carcinoma
Acronym
A retrospective study on other risk features and postoperative adjuvant therapy in oral squamous cell carcinoma
Scientific Title
A retrospective study on other risk features and postoperative adjuvant therapy in oral squamous cell carcinoma
Scientific Title:Acronym
A retrospective study on other risk features and postoperative adjuvant therapy in oral squamous cell carcinoma
Region
| Japan |
Condition
Condition
Oral cancer
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, the clinical significance of poor prognostic factors (other risk features) in oral squamous cell carcinoma, excluding positive resection margins and ENE+, was examined, with the question of which other risk features are the strongest and how many of them should be aggressively treated with postoperative adjuvant therapy being further subdivided.
Basic objectives2
Others
Basic objectives -Others
The results of this study are expected to clarify which patients with other risk features have a higher risk of recurrence/metastasis and should be treated with post-operative adjuvant therapy, and will contribute to future oral surgery practice.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival by number of other risk features.
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
Patients who underwent primary treatment (resection of primary site + cervical dissection) in accordance with NCCN guidelines for oral squamous cell carcinoma between 1 April 2001 and 31 March 2021 at the Department of Oral Surgery, Nagasaki University Hospital.
Key exclusion criteria
i) Cases where sufficient information cannot be obtained due to poor entries in the medical information record.
(ii) Cases with positive post-operative pathology for extranodal invasion and positive resection margins.
Target sample size
114
Research contact person
Name of lead principal investigator
| 1st name | Tomofumi |
| Middle name | |
| Last name | Naruse |
Organization
Nagasaki university
Division name
Department of Clinical Oral Oncology
Zip code
8528588
Address
1-7-1 sakamoto, nagasaki, Japan
TEL
+81958197698
naruse12@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomofumi |
| Middle name | |
| Last name | Naruse |
Organization
Nagasaki university
Division name
Department of Clinical Oral Oncology
Zip code
8528588
Address
1-7-1 sakamoto, nagasaki, Japan
TEL
+81958197698
Homepage URL
naruse12@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
+81958197698
naruse12@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
| 2023 | Year | 04 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 04 | Month | 11 | Day |
Last modified on
| 2023 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057901
| Research Plan | |
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| 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 |
