UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017234 |
|---|---|
| Receipt number | R000019984 |
| Scientific Title | Intraoperative use of spectroscopic detection of protoporphyrin IX from oral 5-aminolevulinic acid on malignant skin tumors during Mohs surgery |
| Date of disclosure of the study information | 2015/04/22 |
| Last modified on | 2015/04/22 14:34:50 |
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Basic information
Public title
Intraoperative use of spectroscopic detection of protoporphyrin IX from oral 5-aminolevulinic acid on malignant skin tumors during Mohs surgery
Acronym
Intraoperative use of 5-aminolevulinic acid on malignant skin tumors during Mohs surgery
Scientific Title
Intraoperative use of spectroscopic detection of protoporphyrin IX from oral 5-aminolevulinic acid on malignant skin tumors during Mohs surgery
Scientific Title:Acronym
Intraoperative use of 5-aminolevulinic acid on malignant skin tumors during Mohs surgery
Region
| Japan |
Condition
Condition
basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)
Classification by specialty
| Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This aimed to conduct a preliminary examination on the accuracy of intraoperative use of photodynamic diagnosis by spectroscopic detection from oral 5-aminolevulinic acid (5-ALA to identify tumor fluorescence from the peritumoral surgical pieces of tissue.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
a resection method using 5-ALA-mediated PDD as a treatment to completely remove malignant skin tumors
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of 5-aminolevulinic acid
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
the patients with malignant skin tumors
Key exclusion criteria
the patient with porphilia
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoru Aoyagi |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Dermatology
Zip code
Address
N15 W7, Kita-ku, Sapporo 060-8638, Japan
TEL
011-706-7387
s.aoyagi@aoyagi-derm.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Aoyagi |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Dermatology
Zip code
Address
N15 W7, Kita-ku, Sapporo 060-8638, Japan
TEL
011-706-7387
Homepage URL
s.aoyagi@aoyagi-derm.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine Department of Dermatology
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2015 | Year | 04 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2010 | Year | 10 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 24 | Day |
Date trial data considered complete
| 2015 | Year | 04 | Month | 24 | Day |
Date analysis concluded
| 2015 | Year | 04 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 22 | Day |
Last modified on
| 2015 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019984
