Cervical DysplasiaNCT02250716
A Comparison of Immediate Treatment of CIN1 With Cryotherapy and 12 Month Cytology Follow up in HIV Seropositive Women
A study testing cryotherapy in people with Cervical Dysplasia, run by University of Witwatersrand, South Africa at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cervical Dysplasia
- What is being tested?
- cryotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteSouth Africa
- Study dates
- Oct 2012to Aug 2016
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Africa1 site
University of Witwatersrand/Helen Joseph Hospital
Johannesburg
About this study
Official title: A Comparison of Immediate Treatment of CIN1 With Cryotherapy and Regular 12 Month Cytology Follow up in HIV Seropositive Women
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.
Read the 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
- Conditions
- Cervical Dysplasia
- Being tested
- cryotherapy
- Keywords
- CIN1, HIV seropositive women, Cryotherapy
- 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
cryotherapy for cervical intraepithelial neoplasia in HIV infected women vs control arm of standard of care (repeat pap smear in 1 year)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Immediate treatment with Cryotherapy and 12 month cytology and histology follow-up Receives: Procedure: cryotherapy |
| Arm 2 | No intervention | 12 month cytology and histology follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regresson of CIN1 to a normal biopsy
Treatment failure is the progression of CIN1 to CIN2
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startOct 2012
- Primary completionAug 2015
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical DysplasiaStudies 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
- 480 participants (estimated)
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
- NCT02250716
- Sponsor's protocol ID
- CIN1
- Status last verified
- Dec 2015
- First submitted
- 23 Sep 2014
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Immediate Treatment of CIN1 With Cryotherapy and Regular 12 Month Cytology Follow up in HIV Seropositive Women
- ClinicalTrials.gov ID
- NCT02250716
- Acronym / sponsor ID
- CIN1
- Conditions
- Cervical Dysplasia
- Keywords
- CIN1, HIV seropositive women, Cryotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- University of Witwatersrand, South AfricaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2016 (estimated)
- First posted
- 26 Sep 2014 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Procedure: cryotherapyImmediate treatment with Cryotherapy and 12 month cytology and histology follow-up |
| Arm 2 | No intervention | –12 month cytology and histology follow-up |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| cryotherapycryotherapy for cervical intraepithelial neoplasia in HIV infected women vs control arm of standard of care (repeat pap smear in 1 year) | Procedure or surgery | Arm 1 |
Primary outcome
Regresson of CIN1 to a normal biopsy
Time frame: 12 month
Treatment failure is the progression of CIN1 to CIN2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
Related trials for Cervical Dysplasia
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingObservational study
Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring
Cervical Cancer, Cervical Dysplasia
RecruitingObservational study
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Endometrial Cancer, Cervical Cancer
Recruiting
Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Screen Positive Women Living With HIV in C1001P-CS2 Kenya
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa
HIV (Human Immunodeficiency Virus), HPV
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 in people with Cervical Dysplasia, 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Dec 2015. 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?
Results are not available in the source record.
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?
Regresson of CIN1 to a normal biopsy (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Dec 2015.