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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025791
Receipt No. R000029661
Scientific Title Feasibility study of sentinel node navigation surgery for head and neck cancer.
Date of disclosure of the study information 2017/03/01
Last modified on 2017/01/21

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Basic information
Public title Feasibility study of sentinel node navigation surgery for head and neck cancer.
Acronym Sentinel node navigation surgery for head and neck cancer.
Scientific Title Feasibility study of sentinel node navigation surgery for head and neck cancer.
Scientific Title:Acronym Sentinel node navigation surgery for head and neck cancer.
Region
Japan

Condition
Condition Head and neck cancer, Oral cancer, Laryngopharyngeal cancer.
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Feasibility, effectiveness, surgical invasiveness is evaluated for head and neck cancer patients who undergo sentinel node naviation surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary endopoint is 5 year disease specific survival
Key secondary outcomes 5 year over all survival, local control rate, cervical lymph node recurrence rate, QOL of shoulder function

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 One day before surgery, 99mTc phytate is injected around the tumor. During surgery, sentinel lymph node is detected and frozen section analysis is performed. In case of metastasis positive, neck dissection is performed and in nagative case, neck dissection is omitted.
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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male
Key inclusion criteria T1-T2,N0 Oral, laryngeal, pharyngeal cancer
Key exclusion criteria Recurrent case after initial treatment.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Tomifuji
Organization National Defense Medical College
Division name Otolaryngology
Zip code
Address 3-2 Namiki, Tokorozawa, Saitama, Japan
TEL 04-2995-1211
Email tomifuji@ndmc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Tomifuji
Organization National Defense Medical College
Division name Otolaryngology
Zip code
Address 3-2 Namiki, Tokorozawa, Saitama, Japan
TEL 04-2995-1211
Homepage URL
Email tomifuji@ndmc.ac.jp

Sponsor
Institute National Defense Medical College
Institute
Department

Funding Source
Organization National Defense Medical College
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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 防衛医科大学校(埼玉県)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 01 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
2017 Year 01 Month 18 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 21 Day
Last modified on
2017 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029661

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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