UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009671 |
|---|---|
| Receipt number | R000011343 |
| Scientific Title | Examination of minimum invasive surgery combined method with trans-oral resection and sentinel lymph node biopsy using an indocyanine green fluorescence in laryngo-pharyngeal cancer patients |
| Date of disclosure of the study information | 2013/01/05 |
| Last modified on | 2013/03/21 22:45:21 |
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Basic information
Public title
Examination of minimum invasive surgery combined method with trans-oral resection and sentinel lymph node biopsy using an indocyanine green fluorescence in laryngo-pharyngeal cancer patients
Acronym
Examination of combined method with trans-oral resection and sentinel lymph node biopsy using an indocyanine green fluorescence in laryngo-pharyngeal cancer patients
Scientific Title
Examination of minimum invasive surgery combined method with trans-oral resection and sentinel lymph node biopsy using an indocyanine green fluorescence in laryngo-pharyngeal cancer patients
Scientific Title:Acronym
Examination of combined method with trans-oral resection and sentinel lymph node biopsy using an indocyanine green fluorescence in laryngo-pharyngeal cancer patients
Region
| Japan |
Condition
Condition
pharyngo-laryngeal cancer
Classification by specialty
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a minimum invasive method for intraoperative detection of lymph node metastasis in head and neck cancer patients without using a radioisotope method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Positivity of lymph node metastasis
Key secondary outcomes
Accuracy of detecting of sentinel nodes
Range of disease free 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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Sentinel node lymph node biopsy metastasis in head and neck cancer patients using an ICG fluorescence 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
1)Previously untreated and clinically negative neck laryngo-pharyngeal (T1-T2) squamous cell carcinoma patients are the candidates for our study.
2)Patient age 20 years and above.
3)Patients who were provided written informed consent.
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)Patient judged by the investigator to be unfit to be enrolled into the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junkichi Yokoyama |
Organization
Juntendo university school of medicine
Division name
Department of Otolaryngology, head and neck surgery
Zip code
Address
2-1-2, Hongo, Bunkyou-ku, Tokyo
TEL
03-3813-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo university school of medicine
Division name
Department of Otolaryngology, head and neck surgery
Zip code
Address
2-1-2, Hongo, Bunkyou-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Juntendo university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Health and Labor Science Reserch Grant for Clinical Cancer Reserch
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 05 | 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 | 11 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 05 | 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
| 2012 | Year | 12 | Month | 30 | Day |
Last modified on
| 2013 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011343
