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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 27 February 2017
Main ID:  JPRN-UMIN000025692
Date of registration: 31/01/2017
Prospective Registration: Yes
Primary sponsor: Hiroshima University
Public title: A clinical study of usefulness of Illumiscan for evaluation of malignancies and mucosa lesions of oral cavity.
Scientific title:
Date of first enrolment: 2017/01/31
Target sample size: 80
Recruitment status: Not yet recruiting
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029459
Study type:  Interventional
Study design:  Single arm Non-randomized  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name: Okamoto Tetsuji 
Address:  1-2-3Kasumi, Minami-ku, Hiroshima-shi, Hiroshima Japan
Telephone: 082-257-5667
Email: testuok@hiroshima-u.ac.jp
Affiliation:  Hiroshima University Hospital Department of Oral and Maxillofacial Surgery
Name: Shigeaki Toratani 
Address:  1-2-3Kasumi, Minami-ku, Hiroshima-shi, Hiroshima Japan
Telephone: 082-257-5667
Email: tora@hiroshima-u.ac.jp
Affiliation:  Hiroshima University Hospital Department of Oral and Maxillofacial Surgery
Key inclusion & exclusion criteria
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.

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


Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female
Health Condition(s) or Problem(s) studied
oral cancer and epithelial dysplasia(leukoplakia or lichen planus etc)
Intervention(s)
1~some weeks
Primary Outcome(s)
Correspondence between the photography image of the lesion and the histopathological exsamination.
Secondary Outcome(s)
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.
Secondary ID(s)
Source(s) of Monetary Support
Hiroshima University
Secondary Sponsor(s)
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