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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041054
Receipt No. R000046883
Scientific Title The effect of photodynamic therapy with talaporfin sodium, a second-generation photosensitizer, on oral squamous cell carcinoma
Date of disclosure of the study information 2020/07/09
Last modified on 2020/07/09

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Basic information
Public title The effect of photodynamic therapy with talaporfin sodium, a second-generation photosensitizer, on oral squamous cell carcinoma
Acronym The effect of photodynamic therapy with talaporfin sodium, a second-generation photosensitizer, on oral squamous cell carcinoma
Scientific Title The effect of photodynamic therapy with talaporfin sodium, a second-generation photosensitizer, on oral squamous cell carcinoma
Scientific Title:Acronym The effect of photodynamic therapy with talaporfin sodium, a second-generation photosensitizer, on oral squamous cell carcinoma
Region
Japan

Condition
Condition oral carcinoma
Classification by specialty
Dental medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 assessment of the anti-cancer effect of talaporfin sodium
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Histopathological finding 6 weeks after treatment
Key secondary outcomes

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 PDT with talaporfin sodium
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
99 years-old >=
Gender Male and Female
Key inclusion criteria tumor size> 6cm
tumor thickness < 5mm
no metastasis
Key exclusion criteria metastasis
treatment term >2 hours
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Hisazumi
Middle name
Last name Ikeda
Organization Nagasaki University
Division name Dep. regenerative Oral Surgery
Zip code 852-8588
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7704
Email sohba@nagasaki-u.a.jp

Public contact
Name of contact person
1st name Hisazumi
Middle name
Last name Ikeda
Organization Sasebo General Hospital
Division name Dentistry
Zip code 857-8511
Address 9-3 Sasebo
TEL 0956-24-1515
Homepage URL
Email hisazumi0115@gmail.com

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Nagasaki University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagasaki Universituy
Address 1-7-1 Sakamoto, naghasaki
Tel 095-819-7704
Email sohba@nagasaki-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 07 Month 09 Day

Related information
URL releasing protocol https://reader.elsevier.com/reader/sd/pii/S1572100017304489?token=027D145FCF7055007FAB140632AA34D2B6
Publication of results Published

Result
URL related to results and publications https://reader.elsevier.com/reader/sd/pii/S1572100017304489?token=027D145FCF7055007FAB140632AA34D2B6
Number of participants that the trial has enrolled 8
Results
Anticancer effect of PDT was confirmed.
Results date posted
2020 Year 07 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
all of them were diagnosed as squamous cell carcinoma.
Participant flow
follow-up fate treatment.
Adverse events
oral mucositis which was expected.
Outcome measures
anticancer effect.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 07 Month 01 Day
Date of IRB
2010 Year 07 Month 30 Day
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2015 Year 04 Month 30 Day
Date of closure to data entry
2015 Year 04 Month 30 Day
Date trial data considered complete
2015 Year 04 Month 30 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 07 Month 09 Day
Last modified on
2020 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046883

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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