UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of optical biopsy using micro-endoscope in tumore cases.
Title of the study (Brief title)	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	Yasushi Naito
Organization	Kobe City Medical Center General Hospital
Division name	Otolaryngology, Head and Neck Surgery
Address	Minatojima-minamimachi, 2-1-1 Chuo-Ku, Kobe
TEL	078-302-4321
Email	naito@kcho.jp

Public contact
Name of contact person	Shogo Shinohara
Organization	Kobe City Medical Center General Hospital
Division name	Otolaryngology, Head and Neck Surgery
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

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 12 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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