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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020217
Receipt No. R000023267
Scientific Title Multicenter Trial on the Ultrasound Diagnostic Criteria of Cervical Lymph Node Metastasis from Head and Neck Cancer
Date of disclosure of the study information 2015/12/17
Last modified on 2018/04/13

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Basic information
Public title Multicenter Trial on the Ultrasound Diagnostic Criteria of Cervical Lymph Node Metastasis from Head and Neck Cancer
Acronym Clinical Study on Ultrasound of Cervical Lymph Node Metastasis (USNLY Study)
Scientific Title Multicenter Trial on the Ultrasound Diagnostic Criteria of Cervical Lymph Node Metastasis from Head and Neck Cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Madoka Furukawa, MD
Organization Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name Department of Head and Neck Surgery
Zip code
Address 2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa Prefecture
TEL 045-520-2222
Email furukawam@kcch.jp

Public contact
Name of contact person
1st name
Middle name
Last name Madoka Furukawa, MD
Organization Kanagawa Cancer Center, Kanagawa Prefectural Hospital Organization
Division name Department of Head and Neck Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2015 Year 08 Month 24 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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