UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049956 |
|---|---|
| Receipt number | R000056895 |
| Scientific Title | Clinicopathlogic significance of extranodal extension(ENE) of cervical lymph nodes of oral squamous cell carcinoma and immunohistological studies of EpCAM expression |
| Date of disclosure of the study information | 2023/01/05 |
| Last modified on | 2023/01/02 18:33:30 |
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Basic information
Public title
Clinicopathlogic significance of extranodal extension(ENE) of cervical lymph nodes of oral squamous cell carcinoma and immunohistological studies of EpCAM expression
Acronym
Immunohistological studies of extranodal extension of cervical lymph nodes of oral squamous cell carcinoma
Scientific Title
Clinicopathlogic significance of extranodal extension(ENE) of cervical lymph nodes of oral squamous cell carcinoma and immunohistological studies of EpCAM expression
Scientific Title:Acronym
Immunohistological studies of extranodal extension of cervical lymph nodes of oral squamous cell carcinoma
Region
| Japan |
Condition
Condition
Oral epithelial cell carcinoma
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the clinicopathologic factors and prognostic relevance of extranodal invasion (ENE) of cervical metastatic lymph nodes in oral squamous epithelial carcinoma.
Basic objectives2
Others
Basic objectives -Others
To classify ENE into ENE+ and ENE- cases, to clarify the usefulness of ENE classification, and to perform immunohistochemical staining using antibodies of EpCAM to clarify the prognostic relevance of EpCAM.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Factors of clinical pathology
Survival rate
Key secondary outcomes
gender, age, pT factor, differentiation, resection margins, adjuvant therapy, distant metastasis
Overall survival, disease-specific survival, local neck control
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 received surgical treatment for squamous cell carcinoma of the oral cavity and underwent cervical dissection between January 8, 2004 and April 12, 2021, and for whom pathological slides confirming the presence of ENE were obtained.
Key exclusion criteria
Cases in which medical information records are poorly documented and insufficient information is not available
Target sample size
174
Research contact person
Name of lead principal investigator
| 1st name | Naruse |
| Middle name | |
| Last name | Tomofumi |
Organization
Nagasaki university hospital
Division name
Oral surgery
Zip code
8528102
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki
TEL
095-819-7698
naruse12@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Naruse |
| Middle name | |
| Last name | Tomofumi |
Organization
Nagasaki university hospital
Division name
Oral surgery
Zip code
8528102
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki
TEL
095-819-7698
Homepage URL
naruse12@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki university hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University Ethical Review Committee
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki
Tel
095-819-7698
None
Secondary IDs
Secondary IDs
YES
Study ID_1
22112104
Org. issuing International ID_1
Nagasaki University Ethical Review Committee
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 | 01 | Month | 05 | 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
174
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2022 | 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 | 01 | Month | 02 | Day |
Last modified on
| 2023 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056895
