UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter Trial on the Ultrasound Diagnostic Criteria of Cervical Lymph Node Metastasis from Head and Neck Cancer
Title of the study (Brief title)	Clinical Study on Ultrasound of Cervical Lymph Node Metastasis (USNLY Study)
Region	Japan

Condition
Condition	Head and Neck Squamous Cell Carcinoma
Classification by specialty	Surgery in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the utility of echographic diagnostic criteria on the cervical lymph node metastasis from head and neck cancer by determining the accuracy in multiple institutes
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Accuracy when using the revised diagnostic criteria of ultrasonography for cervical lymph node metastasis from head and neck cancer
Key secondary outcomes	Exploratory outcomes on variables to predict the accuracy of diagnostic criteria and the difference in the accuracy between institutes

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	1) Patients with head and neck cancer who are planning cervical lymph node dissection 2) Patients who are evaluated for cervical lymph node with ultrasonography 3) Patients who are evaluated for cervical lymph node metastasis pathologically as well as macrographically after the surgery 4) Patients who give written informed consent
Key exclusion criteria	1) Patients with relapsed head and neck cancer previously treated by cervical dissection
Target sample size	106

Research contact person
Name of lead principal investigator	Madoka Furukawa, MD
Organization	Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name	Department of Head and Neck Surgery
Address	2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL	045-520-2222
Email	furukawam@kcch.jp

Public contact
Name of contact person	Madoka Furukawa, MD
Organization	Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name	Department of Head and Neck Surgery
Address	2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL	045-520-2222
Homepage URL
Email	furukawam@kcch.jp

Sponsor
Institute	Kanagawa Cancer Center
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science, The Japan Society of Ultrasonics
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	実施予定施設 1) 新潟県立がんセンター新潟病院頭頸部外科 (新潟県) 2) 岩手医科大学耳鼻咽喉科・頭頸部外科 (岩手県) 3) 金沢医科大学　頭頸部外科 (石川県) 4) 愛知県がんセンター中央病院　頭頸部外科 (愛知県) 5) 名古屋大学医学部付属病院耳鼻咽喉科 (愛知県) 6) 鳥取大学耳鼻咽喉科頭頸部外科 (鳥取県) 7) 宮城県立がんセンター　頭頸部外科 (宮城県) 8) 国立病院機構四国がんセンター　頭頸科 (愛媛県)

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 17 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 08 Month 24 Day
Anticipated trial start date	2015 Year 09 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2021 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Study Design: Prospective Observational Study Subject Recruitment: All patients eligible for this study are being informed at the study sites. The registration period will be between September 24th, 2015 and March 31st, 2019. Of note, the patient registration at each study site should be initiated after IRB approval.

Management information
Registered date	2015 Year 12 Month 16 Day
Last modified on	2018 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023267