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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
