The patients affected by cervical cancer (Ib1-IIa stage) who are candidate for radical hysterectomy and lymphadenectomy will enter in this study. Immediately after anesthesia, 4 ml methylene blue 1% concentration will injected around the tumor. By starting the lymphadenectomy, the colored sentinel lymph nodes-by mentioning their location-will send for pathological evaluation beside the other sentinel lymph nodes. lymphadenectomy in other areas will be done and they will send for pathological evaluation. According to SLN involvement (positive or negative) and the other sentinel lymph nodes involvement, this coloring test sensitivity and property, beside assessing whether it could be considered as a valuable test for predicting the SLN involvement, will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205069656N1
Registration date:2012-06-12, 1391/03/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-06-12, 1391/03/23
Registrant information
Name
Soheila Aminimoghaddam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2280 5193
Email address
s-aminimoghadam@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2013-06-22, 1392/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Detecting the SLN by using methylene blue in the primitive stages of cervical cancer
Public title
Detecting the SLN by using methylene blue in patients affected by cervical cancer in the primitive stages; who were treated by surgical approaches in gynaecology wards in Baghiatallah Azam and Imam Khomeini hospitals
Purpose
Screening
Inclusion/Exclusion criteria
The patients affected by cervical cancer (Ib1-IIa stage) who are candidate for radical hysterectomy and lymphadenectomy will enter in this study.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
Enghelab Sq. Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2011-12-26, 1390/10/05
Ethics committee reference number
41664-13663-30-02-90
Health conditions studied
1
Description of health condition studied
Radical hysterectomy and lymphadenectomy/Cervical cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Biopsy/pathology result
Timepoint
10 days
Method of measurement
Biopsy/Microscope
Secondary outcomes
empty
Intervention groups
1
Description
Dye injection into the SLN
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
Gynaecology ward, Firoozgar hospital
Full name of responsible person
Dr. Soheila Aminimoghaddam
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Oncology ward, Baghiatollahe Azam hospital
Full name of responsible person
Dr. Soheila Aminimoghaddam
Street address
City
Tehran
3
Recruitment center
Name of recruitment center
Oncology ward, Imam Khomeini hospital
Full name of responsible person
Dr. Soheila Aminimoghaddam
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farnoush Golband
Street address
Tehran University of Medical Sciences, Research center
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Gynecology ward , Firoozgar Hospital, Tehran University of Medical Sciences