NCT02956031 Screening Study for Cervical Pre-cancer and Cancer Prevention in South African Women.
| NCT ID | NCT02956031 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pretoria |
| Condition | Cervical Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2016-12 |
| Primary Completion | 2038-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2016-12 with a primary completion date of 2038-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Nearly 8 000 new cervical cancer cases are diagnosed in South Africa per year; many are still undiagnosed and about 50% of diagnosed cases succumb per year. Although the current prevalence of pre-cancer cervical disease is largely unknown, data from local studies suggest regional differences and an increase in the prevalence of cytological abnormalities when compared with historical data. Low frequency in cytology screening is the primary factor attributable to development of invasive cervical cancer and almost one-third of all cervical cancer patients had previous negative cytology. Due to the low sensitivity of cytology it can be assumed that the true prevalence of pre-cancer disease is underestimated by all available data. One round of optimal cervical cytology will detect around 50% of existing pre-cancer cervical disease as identified and proven using colposcopy and directed biopsy. It is now widely accepted that primary screening with a human papilloma virus (HPV) test can improve the sensitivity of screening and that even a single round of HPV screening can rapidly reduce the incidence of invasive cervical cancer and related mortality within a few years. South Africa has a high prevalence of HIV infection and a delay in or failure to initiate antiretroviral therapy (ART). These facts, together with the largely unscreened status of the female population and the high incidence of cervical cancer all suggest that HPV infection and precursors to cervical cancer are both unusually common among South African women. Accurate current knowledge of the performance of newer generation HPV based screening tests in HIV-infected and general female population are essential for cost-analysis and planning for national prevention and screening programs. This study will aim to demonstrate the feasibility and efficacy of new generation HPV deoxyribonucleic acid (DNA) based screening assays in a South African setting. The investigators hypothesize that HPV testing followed by normal and special cytology tests will be a successful screening model for a South African population.
Eligibility Criteria
Inclusion Criteria: * Informed consent accepted and signed * Health seeking behaviour or request for a cervical cancer screening test * Willing and able to receive test result by automated text message or clinic visit Exclusion Criteria: * Current pregnancy * Hysterectomy * Current or previous treatment for gynaecological cancer * Hesitant or unable to undergo screening and treatment if indicated
Contact & Investigator
Greta D Dreyer, PhD
PRINCIPAL INVESTIGATOR
University of Pretoria
Frequently Asked Questions
Who can join the NCT02956031 clinical trial?
This trial is open to female participants only, aged 25 Years or older, up to 75 Years, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02956031 currently recruiting?
Yes, NCT02956031 is actively recruiting participants. Contact the research team at greta.dreyer@up.ac.za for enrollment information.
Where is the NCT02956031 trial being conducted?
This trial is being conducted at Pretoria, South Africa.
Who is sponsoring the NCT02956031 clinical trial?
NCT02956031 is sponsored by University of Pretoria. The principal investigator is Greta D Dreyer, PhD at University of Pretoria. The trial plans to enroll 1,500 participants.
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