UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052150 |
|---|---|
| Receipt number | R000059521 |
| Scientific Title | Retrospective observational study on the extent of invasion in cervical lymph node extravasation cases of oral squamous cell carcinoma |
| Date of disclosure of the study information | 2023/09/08 |
| Last modified on | 2023/09/08 11:55:40 |
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Basic information
Public title
Retrospective observational study on the extent of invasion in cervical lymph node extravasation cases of oral squamous cell carcinoma
Acronym
Observational study of cervical extranodal invasion in oral squamous cell carcinoma
Scientific Title
Retrospective observational study on the extent of invasion in cervical lymph node extravasation cases of oral squamous cell carcinoma
Scientific Title:Acronym
Observational study of cervical extranodal invasion 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, we analyzed the extent of ENE progression and the tumor-occupied status of metastatic lymph nodes in each case, and clarified the relationship between clinicopathological factors and prognosis and the mechanism of extranodal invasion of cervical lymph nodes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of days from treatment start date to event occurrence, with tumor extent and death as events
Key secondary outcomes
Number of days from the start of treatment to event occurrence, with tumor occupying metastatic lymph nodes and death as events
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Cases treated for oral squamous cell carcinoma at Nagasaki University Hospital Oral and Oral Surgery from January 1, 2004 to March 31, 2022
2. Histopathologically it is squamous cell carcinoma.
3. Histopathological findings include metastatic lymph nodes (with or without extranodal invasion).
4. Cases in which primary tumor resection and neck dissection were performed as initial treatment.
Key exclusion criteria
1. Cases treated with preoperative chemotherapy.
2. Cases in which information on treatment details, histopathological findings, and prognosis cannot be obtained from medical records.
Target sample size
40
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
852-8588
Address
Sakamoto, Nagasaki, 1-7-1, Japan
TEL
+81958197698
natsuaya1023@yahoo.co.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
852-8588
Address
Sakamoto, Nagasaki 1-7-1, Japan
TEL
+81958197698
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
+81958197698
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
| 2023 | Year | 09 | Month | 08 | 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 | 09 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 09 | Month | 08 | Day |
Last modified on
| 2023 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059521
