The Purpose of this study is to determine the effect of dendritic cells and tumor antigen complex capability in preventing tumor development. 10 lymphoma subjects will be randomly divided to two equal groups. After antigen priming, one group will receive a median of 6.5 × 1000000 dendritic cells which are subcutaneously injected close to inguinal lymph nodes, twice a day. TCD4 and tumor size will be measured one week after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138712071715N1
Registration date:2009-05-31, 1388/03/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2009-05-31, 1388/03/10
Registrant information
Name
Saeid Abedian
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 335430810151
Email address
sabedian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences and Health Services
Expected recruitment start date
2009-06-22, 1388/04/01
Expected recruitment end date
2011-11-22, 1390/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Vaccination of diffuse B cell lymphoma patients by use of tumor antigens and autologous dendritic cells complex
Public title
Vaccination of cancer patients for preventing cancer development
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Presence of diffuse b cell lymphoma
Exclusion criteria: Presence o any other kind of cancer except for lymphoma
Age
From 40 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
Lymphoma
Secondary trial Id
Registration date
2009-04-05, 1388/01/16
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences and Health Services
Street address
Mazandaran University of Medical Sciences, Imam sqare,
City
Sari
Postal code
Approval date
2009-03-03, 1387/12/13
Ethics committee reference number
116-87
Health conditions studied
1
Description of health condition studied
Lymphoma
ICD-10 code
C85.1
ICD-10 code description
B-cell lymphoma, unspecified
Primary outcomes
1
Description
The number of TCD4
Timepoint
one week after injection
Method of measurement
Flocytometry
2
Description
The number of TCD8
Timepoint
one week after injection
Method of measurement
Flocytometry
Secondary outcomes
1
Description
Interleukin 2
Timepoint
7 to 14 days after injection
Method of measurement
eliza
2
Description
Interleukin 4
Timepoint
7 to 14 days after injection
Method of measurement
ELIZA method
3
Description
Interleukin 10
Timepoint
7 to 14 days after injection
Method of measurement
ELIZA method
4
Description
Interleukin 17
Timepoint
7 to 14 days after injection
Method of measurement
ELIZA method
Intervention groups
1
Description
After antigen priming, subcutaneous injection of median of 6.5 × 1000000 (0.5 ml) dendritic cells, close to inguinal lymph nodes, twice a day
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomaini Hospital
Full name of responsible person
Saeid Abedian
Street address
Medecine collage, Mazandaran University of Medical Sciences
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Saied Abedian
Street address
Medecine collage, Mazandaran University of medical Sciences
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?