Status:
UNKNOWN
A Comparison of Immediate Treatment of CIN1 With Cryotherapy and 12 Month Cytology Follow up in HIV Seropositive Women
Lead Sponsor:
University of Witwatersrand, South Africa
Conditions:
Cervical Dysplasia
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief Summary
Based on the high incidence of cervical cancer and high grade dysplasia and increased progression and incomplete treatment of CIN2 and 3 in South Africa, we propose to study the effect of cryotherapy ...
Detailed Description
Women with HIV have a higher risk of cervical cancer. Screening and treatment formaly of the disease is limited die to poor access of screening programs and multiple visits. Women with HIV also have h...
Eligibility Criteria
Inclusion
- HIV -infected women whose biopsy proves CIN1 and who consent to study participants and procedures
- CIN1 with no visible lesion
- The entire ectocervical lesion should cover less than 75% of the cervix and not more than 2 - 3mm into the endocervical canal
Exclusion
- Pregnant women
- Known and previous treatment for HSIL by any method (Cryotherapy, LEEP or cone biopsy)
- Women who are menstruating or who have active pelvic inflammatory disease will be deferred from the study until the infection is cleared or the menstrual cycle has ended; the patient may then participate in the study.
- Unsatisfactory colposcopic examination defined as inability to see the extent of the lesion in the endocervical canal and lesions deemed ineligible for cryotherapy by an OB/GYN specialist.
- Previous hysterectomy with removal of the cervix
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2016
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT02250716
Start Date
October 1 2012
End Date
August 1 2016
Last Update
December 3 2015
Active Locations (1)
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1
University of Witwatersrand/Helen Joseph Hospital
Johannesburg, South Africa