UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041054 |
|---|---|
| Receipt number | 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 20:48:01 |
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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
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
hisazumi0115@gmail.com
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046883
