UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014557 |
|---|---|
| Receipt number | R000016937 |
| Scientific Title | Clinical research of diagnosis for lymph node metastases of skin cancer by using 5-aminolevulinic acid |
| Date of disclosure of the study information | 2014/07/15 |
| Last modified on | 2017/07/20 14:04:36 |
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Basic information
Public title
Clinical research of diagnosis for lymph node metastases of skin cancer by using 5-aminolevulinic acid
Acronym
Clinical research of diagnosis for lymph node metastases in skin cancer by using 5-ALA
Scientific Title
Clinical research of diagnosis for lymph node metastases of skin cancer by using 5-aminolevulinic acid
Scientific Title:Acronym
Clinical research of diagnosis for lymph node metastases in skin cancer by using 5-ALA
Region
| Japan |
Condition
Condition
skin cancer
Classification by specialty
| Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the acurate diagnosis for skin cancer by using 5-ALA
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
evaluation of the diagnosis rate of the lymph node metastasis
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Administration of 5-aminolevulinic acid before surgery
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
skin cancer diagnosed before surgery
Key exclusion criteria
Porphyria
Recipient of drugs inducing photosensitivity
Pregnant women and women suspected of being pregnant
Patients who did not agree with this study
Patients whom doctors decided as not a candidate.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norito Katoh |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Dermatology
Zip code
Address
465 Kajii-cho Hirokoji Kawaramachi, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5586
nkatoh@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Asai |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Dermatology
Zip code
Address
465 Kajii-cho Hirokoji Kawaramachi, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5586
Homepage URL
jasai@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
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
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
| 2014 | Year | 07 | Month | 15 | 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
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
Terminated
Date of protocol fixation
| 2014 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 15 | Day |
Last modified on
| 2017 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016937
