UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study of lymph node metasitasis without neck dissection classification in oral cancer
Acronym	Clinical study of lymph node metasitasis without neck dissection classification in oral cancer
Scientific Title	Clinical study of lymph node metasitasis without neck dissection classification in oral cancer
Scientific Title:Acronym	Clinical study of lymph node metasitasis without neck dissection classification in oral cancer
Region	Japan

Condition
Condition	Oral cancer
Classification by specialty	Oral surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of the present study is to assess the treatment modality and prognosis on LLN and LRPN in patients diagnosed OSCC.
Basic objectives2	Others
Basic objectives -Others	Future improvements in treatment outcomes will be discussed.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Treatment outcome and prognosis
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent surgery-based treatment for oral squamous cell carcinoma between June 1, 2008 and December 31, 2021, and had metastasis in the outer cervical lymph nodes at the level of oral cancer.
Key exclusion criteria	Cases in which medical information records are poorly documented and insufficient information is available
Target sample size	17

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	1-7-1 Sakamoto, Nagasaki 852-8588, Japan
TEL	0958197698
Email	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	852-8588
Address	1-7-1 Sakamoto, Nagasaki 852-8588, Japan
TEL	+81958197698
Homepage URL
Email	naruse12@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University
Institute
Department

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	Department of Clinical Oral Oncology, Graduate School of Biomedical Sciences, Nagasaki University
Address	1-7-1 Sakamoto, Nagasaki 852-8588, Japan
Tel	0958197698
Email	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	2022 Year 09 Month 13 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	2022 Year 09 Month 13 Day
Date of IRB	2022 Year 09 Month 13 Day
Anticipated trial start date	2022 Year 09 Month 13 Day
Last follow-up date	2022 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	No.

Management information
Registered date	2022 Year 09 Month 13 Day
Last modified on	2022 Year 09 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055745