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Note: This record shows only 22 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:	17 October 2023
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:	A clinical study of usefulness of Illumiscan for evaluation of malignancies and mucosa lesions of oral cavity. - A clinical study of usefulness of Illumiscan for evaluation of malignancies and mucosa lesions of oral cavity.
Date of first enrolment:	2017/01/31
Target sample size:	80
Recruitment status:	Complete: follow-up complete
URL:	https://center6.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:	Shigeaki Toratani
Address:	1-2-3Kasumi, Minami-ku, Hiroshima-shi, Hiroshima 734-8551 Japan
Telephone:	082-257-5667
Email:	tora@hiroshima-u.ac.jp
Affiliation:	Hiroshima University Hospital Department of Oral and Maxillofacial Surgery

Name:	Tetsuji Okamoto
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

Key inclusion & exclusion criteria

Inclusion criteria:
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)

Ethics review

Status: YES
Approval date: 22/12/2016
Contact:

hugcp@hiroshima-u.ac.jp

Hiroshima University hospital IRB

082-257-5596

hugcp@hiroshima-u.ac.jp

Results

Results available:	Yes
Date Posted:
Date Completed:	31/07/2020
URL:

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