UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038988 |
|---|---|
| Receipt number | R000044460 |
| Scientific Title | Study on the utility of the short wavelength cut filter attached to the UVA 1(340~400nm) phototherapy device for Cutaneous T-cell Lymphomas. |
| Date of disclosure of the study information | 2019/12/28 |
| Last modified on | 2020/06/26 08:53:20 |
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Basic information
Public title
Study on the utility of the short wavelength cut filter attached to the UVA 1(340~400nm) phototherapy device for Cutaneous T-cell Lymphomas.
Acronym
Study on the utility of the short wavelength cut filter attached to the phototherapy device for CTCL.
Scientific Title
Study on the utility of the short wavelength cut filter attached to the UVA 1(340~400nm) phototherapy device for Cutaneous T-cell Lymphomas.
Scientific Title:Acronym
Study on the utility of the short wavelength cut filter attached to the UVA 1(340~400nm) phototherapy device for CTCL.
Region
| Japan |
Condition
Condition
Cutaneous T-Cell Lymphomas
Classification by specialty
| Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the short wavelength cut filter attached to the UVA 1(340~400nm) phototherapy device for Cutaneous T-Cell Lymphomas.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
skin pigmentation of irradiation area
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
attached the short wavelength cut filter
Interventions/Control_2
not attached the short wavelength cut filter
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
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 Cutaneous T-cell Lymphomas patients who are candidates for phototherapy.
2 Age between 16 and 65,written approval of patient. If the patient is a minor, the consent is needed from both the patient and the legal representative.
3 Patients who can understand the study and can issue consent to the study in writing.
Key exclusion criteria
1 Patient who is not candidates for phototherapy.
- Patient who will activate or recur malignant skin tumors.
- Patient who has high carcinogenic risk(xeroderma pigmentosum, radiation therapy, internal use or touching career of arsenic etc.)
- Patient who has remarkable photodermatosis(hereditary photodermatosis, albinism, porphyria, photosensitive collagen disease etc.)
2 Patient who participated other clinical studies or trials within 3 months of this study entry.
3 Pregnant or possibly pregnant women, or breastfeeding women. Women who wish to become pregnant during study participation.
4 Patient who is judged inappropriate to participate in the study by the investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Akimichi |
| Middle name | |
| Last name | Morita |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Geriatric and Environmental Dermatology
Zip code
4678601
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL
052-853-8261
amorita@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Akimichi |
| Middle name | |
| Last name | Morita |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Geriatric and Environmental Dermatology
Zip code
4678601
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL
052-853-8261
Homepage URL
amorita@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Department of Geriatric and Environmental Dermatology
Institute
Department
Personal name
Funding Source
Organization
USHIO INC.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University Graduate School of Medical Sciences and Nagoya City University Hospital Institutional Review Board
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
Tel
0528587215
clinical_research@med.nagoya-cu.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
| 2019 | Year | 12 | 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
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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 25 | Day |
Last modified on
| 2020 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044460
