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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025692
Receipt No. R000029459
Scientific Title A clinical study of usefulness of Illumiscan for evaluation of malignancies and mucosa lesions of oral cavity.
Date of disclosure of the study information 2017/01/31
Last modified on 2019/03/26

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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 Open public recruiting
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
2019 Year 03 Month 26 Day


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

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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