UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005706 |
|---|---|
| Receipt number | R000006748 |
| Scientific Title | Multicenter clinical trial of Percutaneous Peptide Immunization for malignant melanoma patients |
| Date of disclosure of the study information | 2011/06/10 |
| Last modified on | 2011/06/02 12:06:36 |
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Basic information
Public title
Multicenter clinical trial of Percutaneous Peptide Immunization for malignant melanoma patients
Acronym
Multicenter clinical trial of Percutaneous Peptide Immunization for malignant melanoma patients
Scientific Title
Multicenter clinical trial of Percutaneous Peptide Immunization for malignant melanoma patients
Scientific Title:Acronym
Multicenter clinical trial of Percutaneous Peptide Immunization for malignant melanoma patients
Region
| Japan |
Condition
Condition
malignant melanoma
Classification by specialty
| Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness and safety of the percutaneous peptide immunization
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Overall survival by status of tumor specific cytotoxic T cell induction
Key secondary outcomes
Induction rate of tumor specific cytotoxic T cell.
Tumor regression
Adverse events
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
| Other |
Interventions/Control_1
Percutaneous immunization
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
Patients with malignant melanoma. HLA-A0201 or HLA-A2402 positive patient.
Key exclusion criteria
Not received chemo therapy within a month. No big metastatic lesion in the liver or in the brain. Not pregnant. Not receiving immunosuppressive agent.
No eczematous lesion on the skin. No hepatitis. No collagen disease.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiharu Fujiyama |
Organization
Hamamatsu University School of Medicine
Division name
Department of Dermatology
Zip code
Address
1-20-1 Handayama Higashi-ku Hamamatsu Shizuoka, Japan
TEL
053-435-2303
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hamamatsu University School of Medicine
Division name
Department of Dermatology
Zip code
Address
1-20-1 Handayama Higashi-ku Hamamatsu Shizuoka, Japan
TEL
053-435-2303
Homepage URL
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Osaka city University, Imayama Syuhei clinic and labo, Shirai dermatology clinic, Aichi Cancer Center
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
| 2011 | Year | 06 | Month | 10 | 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
Completed
Date of protocol fixation
| 2003 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 02 | Day |
Last modified on
| 2011 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006748
