UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041592 |
|---|---|
| Receipt number | R000047393 |
| Scientific Title | Development of Photodynamic diagnosis using 5-ALA for oral cancer and the navigation system during surgery. |
| Date of disclosure of the study information | 2020/08/28 |
| Last modified on | 2020/08/28 16:33:07 |
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Basic information
Public title
Development of Photodynamic diagnosis for oral cancer and the navigation system during surgery.
Acronym
Photodynamic diagnosis using 5-ALA for detection of oral cancer.
Scientific Title
Development of Photodynamic diagnosis using 5-ALA for oral cancer and the navigation system during surgery.
Scientific Title:Acronym
Photodynamic diagnosis using 5-ALA for detection of oral cancer.
Region
| Japan |
Condition
Condition
Oral cancer, Oral precancerous lesion
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of Photodynamic diagnosis for detecting oral cancer and precancerous lesion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Sensitivity, specificity, positive predictive value, and negative predictive value for detection of oral cancer and precancerous lesion by comparing the results of ALA-PDD with histopathological diagnosis.
Key secondary outcomes
incidence rate of adverse events
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
| Medicine | Device,equipment |
Interventions/Control_1
After the topical application of 1% aminolevurinic acid solution for 1-1.5 hour, oral lesions are observed by the novel PDD system, judged whether oral lesions emit red fluorescence and then compared with its histopathological diagnosis. Moreover, a red fluorescence of each oral lesion is qualified. we verify the clinical utility of this system.
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)Patients have suspicious oral cancer and receive a biopsy and resection of oral lesion.
2)Patients sign informed conscent.
Key exclusion criteria
1)Patients with Porphria and photosensitivity
2)Patients with serious medical history(renal insufficiency, hepatic insufficiency)
3)Patients with serious mental disorder
4)Pregnant women or nursing mother.
5)Patients judged to be inappropriate to participate this study by the examiners.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kazuhito |
| Middle name | |
| Last name | Satomura |
Organization
Tsurumi University Dental Hospital
Division name
Department of Oral Medicine
Zip code
230-8501
Address
2-1-3 Tsurumi, Tsurumi-ku, Yokohama city, Kanagawa, Japan
TEL
045-5808326
satomura-k@tsurumi-u.ac.jp
Public contact
Name of contact person
| 1st name | Seiko |
| Middle name | |
| Last name | Tatehara |
Organization
Tsurumi University Dental Hospital.
Division name
Department of Oral Medicine
Zip code
230-8501
Address
2-1-3 Tsurumi, Tsurumi-ku, Yokohama city, Kanagawa, Japan
TEL
045-580-8389
Homepage URL
tatehara-s@tsurumi-u.ac.jp
Sponsor or person
Institute
Tsurumi University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Review Committee of Tsurumi University
Address
2-1-3 Tsurumi, Tsurumi-ku, Yokohama city, Kanagawa, Japan
Tel
045-580-8318
kyoken@tsurumi-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
| 2020 | Year | 08 | Month | 28 | 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
71
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Currently, under article submission
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
| 2013 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 28 | Day |
Last modified on
| 2020 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047393
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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