UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020217
Receipt number 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 13:41:23

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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 or person

Institute

Kanagawa Cancer Center

Institute

Department

Personal name



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

Value
https://center6.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