Cervical Intraepithelial NeoplasiaVICAR2NCT01723956
Validation of Implementation of Cervical Dysplasia Treatment Modalities in HIV-Seropositive Women
A study testing Cryotherapy and LEEP in people with Cervical Intraepithelial Neoplasia, run by University of Witwatersrand, South Africa at 1 site in South Africa.
Trial summary
To compare the efficacy of cryotherapy and large loop excision of the transformation zone (LLETZ) procedures for the treatment of high-grade cervical intra-epithelial neoplasia (CIN2/3) among HIV-seropositive women by follow-up VIA, cytology and Human Papillomavirus. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia
- What is being tested?
- Cryotherapy and LEEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteSouth Africa
- Study dates
- Mar 2010to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 18-65 years of age
- Not menstruating (if menstruating, the patient can be screened at another date)
- Able to sign consent
- Able to follow the study protocol
- HIV positive (by two different criteria; either 2 different rapid HPV tests of different manufacturers, a HIV viral load ≥5,000,ELISA, Western blot documented in VICAR 1)
- Participant with histology-proven CIN 2 or 3 disease
Who cannot join
- Pregnant
- Clinically active sexually transmitted disease determined by clinical history and/or physical exam (may participate after adequate treatment by syndromic treatment management)
- Known and previous treatment for high grade squamouse intraepithelial lesion by any method (cryotherapy, LLETZ or cone biopsy)
- Previous hysterectomy with removal of the cervix
- Significant medical illness/mental illness that the investigator feels would prevent the participant from complying with the protocol or place the participant at medical risk
- Cervical dysplastic lesions that are not appropriate for cryotherapy, defined as the following:
Show all 10Show fewer
- Lesion is greater than ≥75% cervix
- Lesion entering into the cervical canal and the complete lesion cannot be visualized
- Presence of abnormal vasculature
- Lesion bigger that the cryotherapy probe
Trial locations and contacts
1 site in 1 country.
About this study
To compare the efficacy of cryotherapy and large loop excision of the transformation zone (LLETZ) procedures for the treatment of high-grade cervical intra-epithelial neoplasia (CIN2/3) among HIV-seropositive women by follow-up VIA, cytology and Human Papillomavirus.
Hypothesis: LEEP will be more effective than cryotherapy in removing CIN 2/3 lesions in HIV positive women in South Africa
Read the detailed description
Cervical cancer is the most common cancer in HIV positive women. This is due to immunosuppression and lack of organized and effective screening and treatment programs in Africa. Other screening and treatment modalities need to be evaluated in resource limited countries as there is not capacity in most of these countries to implement a cytology/histology based program. The treatment modality of cryotherapy is easy to train and perform and can be done by a nurse. LEEP requires significant training usually doctors and skills in administering local anaesthetic. This study compares the two modalities of cryotherapy vs LEEP in a randomized controlled study in HIV positive women in South Africa.
- PRIMARY AIMS (S.A.):
- To compare the efficacy of cryotherapy and large loop excision of the transformation zone (LLETZ) procedures for the treatment of high-grade cervical intra-epithelial neoplasia (CIN2/3) among HIV-seropositive women by follow-up VIA, cytology and HPV.
- To determine the utility of subsequent HPV DNA testing as a marker of effective treatment following the treatment of CIN 2/3 among HIV-seropositive women.
- To compare the safety of cryotherapy versus LLETZ in HIV seropositive women.
SECONDARY AIMS:
- To describe HIV disease status (CD4, HIV viral load), demographics, and sexual behavior in each treatment arm (LLETZ and cryotherapy) in HIV seropositive women.
- To determine the cervical disease recurrence rates with cryotherapy and LLETZ.
- To evaluate the relationship between HIV status, demographics, HPV, and sexual behavior with the clearance of cervical disease at the ectocervical and endocervical margins in HIV seropositive women.
- Conditions
- Cervical Intraepithelial Neoplasia
- Being tested
- Cryotherapy, LEEP
- Keywords
- Cervical Dysplasia, Cin 2, Cin 3, HIV positive women, South Africa
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyProcedure or surgery
Also called This is a study using Freezing with a cryogun
This is involves freezing the lesions with a cryo gun using Nitrous Oxide for 3 minutes-- wait 5 minutes and then refreezing for 3 more minutes. This procedure uses the Wallach cryogun
LEEPProcedure or surgery
Also called Loop Electric Excision Procedure
The cervix is anaesthetized with lidocaine and then a electric loop is applied to the cervical lesion which is cut with one pass. The LEEP machine used is the automatic Finesse Machine.
| Study group | Role | What they receive |
|---|---|---|
| Arm B | Active comparator | LEEP treatment of CIN 2/3 cervical lesion in HIV positive women (standard of Care) Receives: Procedure: LEEP |
| Arm A | Experimental | Cryotherapy treatment of CIN 2/3 cervical lesions Receives: Procedure: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare efficacy of cryotherapy and LEEP
To compare the efficacy of cryotherapy and large loop excision of the transformation zone (LLETZ) procedures for the treatment of high-grade cervical intra-epithelial neoplasia (CIN2/3) among HIV-seropositive women by follow-up VIA, cytology and HPV.
Measured: 1 year
Secondary outcomes (4)
The ability to use Human Papillomavirus as the measure of treatment success
To determine the utility of subsequent HPV DNA testing as a marker of effective treatment following the treatment of CIN 2/3 among HIV-seropositive women.
Measured: 1 year
To compare the safety of cryotherapy versus LLETZ in HIV seropositive women
To compare the safety of cryotherapy versus LLETZ in HIV seropositive women by evaluating adverse events as measured by the Division of AIDS toxicity table 2004 (revised August 2010)
Measured: 1 month, 6 months and 12 months
Describe factors associated with successful treatment of CIN 2/3
To describe HIV disease status (CD4, HIV viral load), demographics, tissue margins and sexual behavior in each treatment arm (LLETZ and cryotherapy) in HIV seropositive women.
Measured: 1 year
To determine the cervical disease recurrence rates with cryotherapy and LLETZ.
To determine the cervical disease recurrence rates with cryotherapy and LLETZ at 6 months and 12 months by colposcopy
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2012 (estimated)
- Study startMar 2010
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witwatersrand, South Africa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cynthia S Firnhaber, University of Witwatersrand, South Africa
- Investigators
- Cynthia S Firnhaber, MD, Principal investigator, University of Witwatersrand, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723956
- Sponsor's protocol ID
- ZA.09.0265
- Acronym
- VICAR2
- Status last verified
- Aug 2014
- First submitted
- 6 Nov 2012
- Last updated
- 22 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Smith JS, Sanusi B, Swarts A, Faesen M, Levin S, Goeieman B, Ramotshela S, Rakhombe N, Williamson AL, Michelow P, Omar T, Hudgens MG, Firnhaber C. A randomized clinical trial comparing cervical dysplasia treatment with cryotherapy vs loop electrosurgical excision procedure in HIV-seropositive women from Johannesburg, South Africa. Am J Obstet Gynecol. 2017 Aug;217(2):183.e1-183.e11. doi: 10.1016/j.ajog.2017.03.022. Epub 2017 Mar 31.
PubMed 28366730
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Implementation of Cervical Dysplasia Treatment Modalities in HIV-Seropositive Women
- ClinicalTrials.gov ID
- NCT01723956
- Acronym / sponsor ID
- VICAR2 / ZA.09.0265
- Conditions
- Cervical Intraepithelial Neoplasia
- Keywords
- Cervical Dysplasia, Cin 2, Cin 3, HIV positive women, South Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- University of Witwatersrand, South AfricaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy of cryotherapy and large loop excision of the transformation zone (LLETZ) procedures for the treatment of high-grade cervical intra-epithelial neoplasia (CIN2/3) among HIV-seropositive women by follow-up VIA, cytology and Human Papillomavirus.
Hypothesis: LEEP will be more effective than cryotherapy in removing CIN 2/3 lesions in HIV positive women in South Africa
Detailed description
Cervical cancer is the most common cancer in HIV positive women. This is due to immunosuppression and lack of organized and effective screening and treatment programs in Africa. Other screening and treatment modalities need to be evaluated in resource limited countries as there is not capacity in most of these countries to implement a cytology/histology based program. The treatment modality of cryotherapy is easy to train and perform and can be done by a nurse. LEEP requires significant training usually doctors and skills in administering local anaesthetic. This study compares the two modalities of cryotherapy vs LEEP in a randomized controlled study in HIV positive women in South Africa.
- PRIMARY AIMS (S.A.):
- To compare the efficacy of cryotherapy and large loop excision of the transformation zone (LLETZ) procedures for the treatment of high-grade cervical intra-epithelial neoplasia (CIN2/3) among HIV-seropositive women by follow-up VIA, cytology and HPV.
- To determine the utility of subsequent HPV DNA testing as a marker of effective treatment following the treatment of CIN 2/3 among HIV-seropositive women.
- To compare the safety of cryotherapy versus LLETZ in HIV seropositive women.
SECONDARY AIMS:
- To describe HIV disease status (CD4, HIV viral load), demographics, and sexual behavior in each treatment arm (LLETZ and cryotherapy) in HIV seropositive women.
- To determine the cervical disease recurrence rates with cryotherapy and LLETZ.
- To evaluate the relationship between HIV status, demographics, HPV, and sexual behavior with the clearance of cervical disease at the ectocervical and endocervical margins in HIV seropositive women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm B | Active comparator | Procedure: LEEPLEEP treatment of CIN 2/3 cervical lesion in HIV positive women (standard of Care) |
| Arm A | Experimental | Procedure: CryotherapyCryotherapy treatment of CIN 2/3 cervical lesions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women 18-65 years of age
- Not menstruating (if menstruating, the patient can be screened at another date)
- Able to sign consent
- Able to follow the study protocol
- HIV positive (by two different criteria; either 2 different rapid HPV tests of different manufacturers, a HIV viral load ≥5,000,ELISA, Western blot documented in VICAR 1)
Key exclusion criteria (10 listed)
- Pregnant
- Clinically active sexually transmitted disease determined by clinical history and/or physical exam (may participate after adequate treatment by syndromic treatment management)
- Known and previous treatment for high grade squamouse intraepithelial lesion by any method (cryotherapy, LLETZ or cone biopsy)
- Previous hysterectomy with removal of the cervix
- Significant medical illness/mental illness that the investigator feels would prevent the participant from complying with the protocol or place the participant at medical risk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryotherapyAlso: This is a study using Freezing with a cryogunThis is involves freezing the lesions with a cryo gun using Nitrous Oxide for 3 minutes-- wait 5 minutes and then refreezing for 3 more minutes. This procedure uses the Wallach cryogun | Procedure or surgery | Arm A |
| LEEPAlso: Loop Electric Excision ProcedureThe cervix is anaesthetized with lidocaine and then a electric loop is applied to the cervical lesion which is cut with one pass. The LEEP machine used is the automatic Finesse Machine. | Procedure or surgery | Arm B |
Primary outcome
Compare efficacy of cryotherapy and LEEP
Time frame: 1 year
To compare the efficacy of cryotherapy and large loop excision of the transformation zone (LLETZ) procedures for the treatment of high-grade cervical intra-epithelial neoplasia (CIN2/3) among HIV-seropositive women by follow-up VIA, cytology and HPV.
4 secondary outcomes
The ability to use Human Papillomavirus as the measure of treatment success
Time frame: 1 year
To compare the safety of cryotherapy versus LLETZ in HIV seropositive women
Time frame: 1 month, 6 months and 12 months
Describe factors associated with successful treatment of CIN 2/3
Time frame: 1 year
To determine the cervical disease recurrence rates with cryotherapy and LLETZ.
Time frame: 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2014.
- Derived from this study: PubMed 28366730Smith JS, Sanusi B, Swarts A, Faesen M, Levin S, Goeieman B, Ramotshela S, Rakhombe N, Williamson AL, Michelow P, Omar T, Hudgens MG, Firnhaber C. A randomized clinical trial comparing cervical dysplasia treatment with cryotherapy vs loop electrosurgical excision procedure in HIV-seropositive women from Johannesburg, South Africa. Am J Obstet Gynecol. 2017 Aug;217(2):183.e1-183.e11. doi: 10.1016/j.ajog.2017.03.022. Epub 2017 Mar 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia S Firnhaber, MD principal investigator
University of Witwatersrand, South Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy and LEEP in people with Cervical Intraepithelial Neoplasia, run by University of Witwatersrand, South Africa at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare efficacy of cryotherapy and LEEP (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01723956, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2014.