UMIN-CTR Clinical Trial

Basic information
Public title	A clinical study of usefulness of Illumiscan for evaluation of malignancies and mucosa lesions of oral cavity.
Acronym	A clinical study of usefulness of Illumiscan for evaluation of malignancies and mucosa lesions of oral cavity.
Scientific Title	A clinical study of usefulness of Illumiscan for evaluation of malignancies and mucosa lesions of oral cavity.
Scientific Title:Acronym	A clinical study of usefulness of Illumiscan for evaluation of malignancies and mucosa lesions of oral cavity.
Region	Japan

Condition
Condition	oral cancer and epithelial dysplasia(leukoplakia or lichen planus etc)
Classification by specialty	Oral surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We observe superficial malignant lesions and epithelial dysplasia(leukoplakia or lichen planus etc)using Illumiscan which is a fluorescence observer and decide the area of lesions. In addition we investigate the capacity of Illumiscan for visualization of the area of oral cancer by comparing with the histopathological examination of the excision specimens.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correspondence between the photography image of the lesion and the histopathological exsamination.
Key secondary outcomes	Comparison between excision range based on the iodo-staining and fluorescence loss range of Illumiscan photography image of the lesion. Comparison of the existence range of a malignant cell and the epithelium dysplasia between Illumiscan photography image and the histopathological exsamination of the excision specimen.

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	Device,equipment
Interventions/Control_1	1~some weeks
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.The patient who has oral cancer, lichen planus, epithelium dysplasia. (non-treatment, existing treatment, having recurrence or not do not matter.) 2.The person who undergoes a histopathological examination of the lesion. 3.Age at the time of the agreement acquisition is a patient 20 years or older. 4.The patient that an agreement is provided in a document about the participation of this study.
Key exclusion criteria	1.The patient who has a mental disease, convulsions attack having poor control and a paroxysmal disease as complications 2.In addition, the patient who judged that the study medical attendant was unsuitable for the object of this study
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Tetsuji Middle name Last name Okamoto
Organization	Hiroshima University Hospital
Division name	Department of Oral and Maxillofacial Surgery
Zip code	734-8551
Address	1-2-3Kasumi, Minami-ku, Hiroshima-shi, Hiroshima
TEL	082-257-5667
Email	testuok@hiroshima-u.ac.jp

Public contact
Name of contact person	1st name Shigeaki Middle name Last name Toratani
Organization	Hiroshima University Hospital
Division name	Department of Oral and Maxillofacial Surgery
Zip code	734-8551
Address	1-2-3Kasumi, Minami-ku, Hiroshima-shi, Hiroshima
TEL	082-257-5667
Homepage URL
Email	tora@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	Hiroshima University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Hiroshima University hospital IRB
Address	1-2-3, Kasumi, Minami-ku, Hiroshima, 734-8551, Japan
Tel	082-257-5596
Email	hugcp@hiroshima-u.ac.jp

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	2017 Year 01 Month 31 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	Completed
Date of protocol fixation	2016 Year 12 Month 14 Day
Date of IRB	2016 Year 12 Month 22 Day
Anticipated trial start date	2017 Year 01 Month 31 Day
Last follow-up date	2020 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 16 Day
Last modified on	2020 Year 11 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029459