UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001624 |
|---|---|
| Receipt number | R000001951 |
| Scientific Title | Safety of intradermal administration of monosodium urate crystals as a carrier of idiotype cancer vaccine |
| Date of disclosure of the study information | 2009/01/07 |
| Last modified on | 2012/04/20 12:11:08 |
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Basic information
Public title
Safety of intradermal administration of monosodium urate crystals as a carrier of idiotype cancer vaccine
Acronym
Safety of intradermal administration of monosodium urate crystals
Scientific Title
Safety of intradermal administration of monosodium urate crystals as a carrier of idiotype cancer vaccine
Scientific Title:Acronym
Safety of intradermal administration of monosodium urate crystals
Region
| Japan |
Condition
Condition
multiple myeloma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To certify the safety of inradermal administration of monosodium urate crystals as idiotype cancer vaccine for patients with multiple myeloma
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Safetiness during three weeks following the administration of monosodium urate crystals
Key secondary outcomes
Serum level of inflammatory cytokines
Decndritic cell count in the peripheral blood
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intradermal administration of monosodium urate crystals
2.0 mcg of monosodium urate crystals per administration
Interventions/Control_2
20 mcg of monosodium urate crystals per administration
Interventions/Control_3
200 mcg of monosodium urate crystals per administration
Interventions/Control_4
2.0 mg of monosodium urate crystals per administration
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy volunteer under aged 60 who agreed to participate in writing
Key exclusion criteria
1) Adolecents having major organ injury indicated by elevated level of serum creatinine, total bilirubin or ALT , or having symptomatic congestive heart failure
2) Patients suffering from gout
3) Patients with any of active autoimmune disease
4) Patients with any of active infectious disease
5) Women on (possible) pregnancy or lactation
6) Adolecents judged inadequate by doctor in charge of the patient or the study
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tsutani |
Organization
National Hospital Organization Awara Hospital
Division name
Department of Internal Medicine
Zip code
Address
238-1 Kitagata, Awara, Fukui 910-4272, Japan
TEL
0776-79-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuaki Tanaka |
Organization
National Hospital Organization Awara Hospital
Division name
Department of Pharmacy
Zip code
Address
238-1 Kitagata, Awara, Fukui 910-4272, Japan
TEL
0776-79-1211
Homepage URL
http://www.hosp.go.jp/~awara/kenkyu.html
nhoawara-secretary@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization Awara Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Awara Hospital
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
| 2009 | Year | 01 | Month | 07 | 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
| 2007 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 01 | Month | 07 | Day |
Last modified on
| 2012 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001951
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
