UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007824 |
|---|---|
| Receipt number | 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 23:37:50 |
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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
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
Sponsor or person
Institute
Juntendo univercity
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009218
