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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004951
Receipt No. R000005894
Scientific Title Evaluation of selective neck dissections based on sentinel lymph node navigation in oral cancers
Date of disclosure of the study information 2011/02/01
Last modified on 2017/01/29

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Basic information
Public title Evaluation of selective neck dissections based on sentinel lymph node navigation in oral cancers
Acronym Sentinel lymph node navigation surgery in oral cancers
Scientific Title Evaluation of selective neck dissections based on sentinel lymph node navigation in oral cancers
Scientific Title:Acronym Sentinel lymph node navigation surgery in oral cancers
Region
Japan

Condition
Condition Oral cancer
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of the study is to evaluate the validity of selective neck dissections based on sentinel lymph node navigation in N0 oral cancer patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes We evaluate the false negative rate of selective neck dissections based on sentinel lymph node status.
Key secondary outcomes We focus on the accuracy of detecting of sentinel nodes and intraoperative diagnoses of their status, the false negative rate in follow-up and impact on patient survival.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Selective neck dissections based on sentinel lymph node navigation
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Previously untreated and clinically negative neck oral squamous cell carcinoma patients (late T2 and T3) are the candidates for our study.
Key exclusion criteria 1)Previously treated patients
2)A history of radiation therapy for the neck
3)Pregnancy or lactating women, or women with suspected pregnancy
4)Patients judged by the investigator to be unfit to be enrolled into the study
Target sample size 56

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhisa Hasegawa
Organization Aichi Cancer Center
Division name Department of Head and Neck Surgery
Zip code
Address 1-1 Kanokoden Chikusaku, Nagoya 464-8681
TEL 052-762-6111
Email hasegawa@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhisa Hasegawa
Organization Aichi Cancer Center
Division name Department of Head and Neck Surgery
Zip code
Address 1-1 Kanokoden Chikusaku, Nagoya 464-8681
TEL 052-762-6111
Homepage URL
Email hasegawa@aichi-cc.jp

Sponsor
Institute Aichi Cancer Center
Institute
Department

Funding Source
Organization Health and Labor Sciences Research Grant for Clinical Cancer Research (H21-Gannorinshou-Ippan-016)
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2009 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2013 Year 12 Month 01 Day
Date of closure to data entry
2014 Year 06 Month 01 Day
Date trial data considered complete
2014 Year 06 Month 01 Day
Date analysis concluded
2014 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 01 Month 25 Day
Last modified on
2017 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005894

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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