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Recruitment status
Unique ID issued by UMIN UMIN000025320
Receipt No. R000029124
Scientific Title Evaluation of optical biopsy using micro-endoscope in tumore cases.
Date of disclosure of the study information 2016/12/19
Last modified on 2016/12/18

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Basic information
Public title Evaluation of optical biopsy using micro-endoscope in tumore cases.
Acronym Optical Biopsy in Head and Neck tumors.
Scientific Title Evaluation of optical biopsy using micro-endoscope in tumore cases.
Scientific Title:Acronym Optical Biopsy in Head and Neck tumors.
Region
Japan

Condition
Condition Head and Neck tumor cases
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We perform optical biopsy using micro-endoscope to the dissected specimen of head and neck tumor cases with or without rapid labelling by fluorescence dyes. By comparing opital biopsy and patho-histological examination, the way of fluorescence labelling and of optical examination will be optimized. We will reveal how much histo and pathological information useful for diagnosis is available through optical biopsy against the specimen right after surgical removal.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes We expect that we can evaluate the efficacy of optical biopsy in the online onsite path-histological diagnosis in head and neck tumor cases.
Key secondary outcomes Pre-and peri-operative evaluation of tumors will be done more easily, quickly and precisely, once the optical bipopsy technique becomes available.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
0 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Head and Neck tumor cases who will receive surgical resection of tumors at Kobe City Medical Center Head and Neck Surgery Department.
Key exclusion criteria N.A.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Naito
Organization Kobe City Medical Center General Hospital
Division name Otolaryngology, Head and Neck Surgery
Zip code
Address Minatojima-minamimachi, 2-1-1 Chuo-Ku, Kobe
TEL 078-302-4321
Email naito@kcho.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shogo Shinohara
Organization Kobe City Medical Center General Hospital
Division name Otolaryngology, Head and Neck Surgery
Zip code
Address Minatojima-minamimachi, 2-1-1 Chuo-Ku, Kobe
TEL 078-302-4321
Homepage URL
Email sinosino@kcho.jp

Sponsor
Institute Kobe City Medical Center General Hospital,
Otolaryngology, Head and Neck Surgery
Institute
Department

Funding Source
Organization Japanese Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) The Uehara Memorial Foundation

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 神戸市立医療センター中央市民病院 (兵庫県)

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 19 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
Date of protocol fixation
2016 Year 12 Month 18 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The study has just started.

Management information
Registered date
2016 Year 12 Month 18 Day
Last modified on
2016 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029124

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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