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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000009671
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Juntendo university school of medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011343

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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