UMIN-CTR Clinical Trial

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
Email	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
Email	tatehara-s@tsurumi-u.ac.jp

Sponsor
Institute	Tsurumi University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047393