Back to resultsA Comparison of Immediate Treatment of CIN1 With Cryotherapy and 12 Month Cytology Follow up in HIV Seropositive Women
Primary Purpose
Cervical Dysplasia
Status
Unknown status
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
cryotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Dysplasia focused on measuring CIN1, HIV seropositive women, Cryotherapy
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- University of Witwatersrand/Helen Joseph Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Arm 1
Arm 2
Arm Description
Immediate treatment with Cryotherapy and 12 month cytology and histology follow-up
12 month cytology and histology follow-up
Outcomes
Primary Outcome Measures
Regresson of CIN1 to a normal biopsy
Treatment failure is the progression of CIN1 to CIN2
Secondary Outcome Measures
Full Information
NCT ID
NCT02250716
First Posted
September 23, 2014
Last Updated
December 1, 2015
Sponsor
University of Witwatersrand, South Africa
1. Study Identification
Unique Protocol Identification Number
NCT02250716
Brief Title
A Comparison of Immediate Treatment of CIN1 With Cryotherapy and 12 Month Cytology Follow up in HIV Seropositive Women
Official Title
A Comparison of Immediate Treatment of CIN1 With Cryotherapy and Regular 12 Month Cytology Follow up in HIV Seropositive Women
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Witwatersrand, South Africa
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 among HIV-positive women diagnosed with CIN 1 versus regular 12 month cytology follow-up. This study will be a dual-arm, open-label, randomized clinical trial for HIV-infected women diagnosed with CIN 1 and receiving care at the Themba Lethu Clinic, Helen Joseph Hospital, Johannesburg, South Africa. CIN 1 will be identified from patients who have had a colposcopic biopsy for persistent LSIL as per standard of care.
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 high progressions rates of disease amd my need to be treated earliers. Cryotherapy is a low option and very easy to implement especially in low resource provinces.
It is cheaper and easier to administer than Large Loop electrosurgical excision procedure (LLETZ)
No histology or transportation costs of specimens
Less invasive than LLETZ
It is nurse driven and easily learned
It decreases loss to follow-up of patients due to reduced waiting time, transportation costs, time off work and HIV stigma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dysplasia
Keywords
CIN1, HIV seropositive women, Cryotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Immediate treatment with Cryotherapy and 12 month cytology and histology follow-up
Arm Title
Arm 2
Arm Type
No Intervention
Arm Description
12 month cytology and histology follow-up
Intervention Type
Procedure
Intervention Name(s)
cryotherapy
Intervention Description
cryotherapy for cervical intraepithelial neoplasia in HIV infected women vs control arm of standard of care (repeat pap smear in 1 year)
Primary Outcome Measure Information:
Title
Regresson of CIN1 to a normal biopsy
Description
Treatment failure is the progression of CIN1 to CIN2
Time Frame
12 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia S Firnhaber, MD
Organizational Affiliation
University of Witwatersrand, South Africa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Witwatersrand/Helen Joseph Hospital
City
Johannesburg
Country
South Africa
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Immediate Treatment of CIN1 With Cryotherapy and 12 Month Cytology Follow up in HIV Seropositive Women
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