UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025320 |
|---|---|
| Receipt number | 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 23:19:20 |
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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
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
sinosino@kcho.jp
Sponsor or person
Institute
Kobe City Medical Center General Hospital,
Otolaryngology, Head and Neck Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029124
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
