UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058020 |
|---|---|
| Receipt number | R000066320 |
| Scientific Title | A study on the extent of progression of extra-nodal invasion in cervical lymph node metastasis in oral cancer |
| Date of disclosure of the study information | 2025/05/30 |
| Last modified on | 2025/05/30 07:16:38 |
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Basic information
Public title
A study on the extent of progression of extra-nodal invasion in cervical lymph node metastasis in oral cancer
Acronym
A study on the extent of progression of extra-nodal invasion in cervical lymph node metastasis in oral cancer
Scientific Title
A study on the extent of progression of extra-nodal invasion in cervical lymph node metastasis in oral cancer
Scientific Title:Acronym
A study on the extent of progression of extra-nodal invasion in cervical lymph node metastasis in oral cancer
Region
| Japan |
Condition
Condition
Oral cancer
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In addition to the distance of progression, we classify the status of tumor involvement in the metastatic lymph nodes and perform clinical pathological examinations. We also examine the expression of immune checkpoint molecules at the infiltrative tips of metastatic lymph nodes using immunohistochemical staining.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disease specific survival
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 oral cancer at the Department of Oral and Maxillofacial Surgery, Nagasaki University Hospital, from January 1, 2004, to May 30, 2022.
Cases in which primary tumor resection and neck dissection were performed simultaneously during initial treatment.
Cases in which the primary tumor was diagnosed as squamous cell carcinoma by histopathological examination and ENE was detected in the metastatic lymph nodes.
Key exclusion criteria
Cases that underwent preoperative chemotherapy.
Cases for which information on treatment, pathological findings, and prognosis could not be obtained from medical records.
Target sample size
41
Research contact person
Name of lead principal investigator
| 1st name | Hiromasa |
| Middle name | |
| Last name | Fukushima |
Organization
Nagasaki University
Division name
Department of Oral surgery
Zip code
852-8588
Address
1-7-1, sakamoto, nagasaki, Japan
TEL
095-819-7698
natsuaya1023@yahoo.co.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
natsuaya1023@yahoo.co.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
natsuaya1023@yahoo.co.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
| 2025 | Year | 05 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2025 | 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
| 2025 | Year | 05 | Month | 30 | Day |
Last modified on
| 2025 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066320
