UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025692 |
|---|---|
| Receipt number | 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 | 2020/11/09 09:28:35 |
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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
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
tora@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029459
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| Registered date | File name |
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