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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000007824
Receipt No. R000009218
Scientific Title Availability of sentinel lymph node biopsy of thyroid cancer using indocyanine green fluorometric method and radioisotope method
Date of disclosure of the study information 2012/04/23
Last modified on 2012/04/23

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Basic information
Public title Availability of sentinel lymph node biopsy of thyroid cancer using indocyanine green fluorometric method and radioisotope method
Acronym Availability of sentinel lymph node biopsy of thyroid cancer
Scientific Title Availability of sentinel lymph node biopsy of thyroid cancer using indocyanine green fluorometric method and radioisotope method
Scientific Title:Acronym Availability of sentinel lymph node biopsy of thyroid cancer
Region
Japan

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

Objectives
Narrative objectives1 To investigate availability of sentinel lymph node biopsy of thyroid cancer.
To investigate which method is more reasonable in price and high in quuality by comparing ICG method and RI method.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes We focus on the accuracy of detecting of sentinel nodes using an ICG fluorescence method.
Key secondary outcomes

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 Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 We perform the sentinel node lymph node biopsy metastasis in thyroid cancer patients using an ICG fluorescence method and a RI method.
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

Not applicable
Gender Male and Female
Key inclusion criteria Clinically negative neck metastasis thyroid carcinoma(T2-T4,N0,M0) patients are the candidates for our study.
Key exclusion criteria Pregnancy or lactating women, or women with suspected pregnancy
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junkichi Yokoyama
Organization Juntendo univercity
Division name Otorhinolaryngology
Zip code
Address 2-1-1 Hongo Bunkyo-ku Tokyo Japan
TEL 03-3813-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Junkichi Yokoyama
Organization Juntendo univercity
Division name Otorhinolaryngology
Zip code
Address 2-1-1 Hongo Bunkyo-ku Tokyo Japan
TEL 03-3813-3111
Homepage URL
Email

Sponsor
Institute Juntendo univercity
Institute
Department

Funding Source
Organization Juntendo univercity
Organization
Division
Category of Funding Organization Self funding
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 順天堂大学順天堂医院(東京都)

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 23 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 Preinitiation
Date of protocol fixation
2012 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
2013 Year 03 Month 01 Day
Date trial data considered complete
2013 Year 03 Month 01 Day
Date analysis concluded
2014 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 04 Month 23 Day
Last modified on
2012 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009218

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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