An observational study in Cervical Cancer, High Grade Sil and CIN2, sponsored by University of Pretoria. Recruiting at 1 site in South Africa. Open to female participants aged 25 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by University of Pretoria · Observational
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.
2,366 studies on the registry are indexed under Uterine Cervical Neoplasms; 677 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 225 across 529 observational studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →University of Pretoria is the lead sponsor of 17 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This is a multicentric study carried out in South Africa. Women with unknown HIV status will be recruited from the general population, and HIV positive women from adult antiretroviral treatment (ART) clinics.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
those who serologically tested positive for HIV
Other: Screening · Other: Colposcopy · Procedure: LLETZ
those who serologically tested negative for HIV
Other: Screening · Other: Colposcopy · Procedure: LLETZ
those with no available serological test for HIV
Other: Screening · Other: Colposcopy · Procedure: LLETZ
Cervical specimen obtained using speculum examination and cervical collection bush.
Vaginal speculum examination followed by application of 2% acetic acid and lugol's iodine with inspection with colposcope and punch biopsies taken of abnormal areas.
The above (see colposcopy) is followed by local anaesthetic with two dentist's ampoules of lignocaine and large loop excision using coagulation of the abnormal area (usually 2 x 3 x 1 cm).
Number of women with histologically proven cervical intraepithelial neoplasia grade 2+ (CIN2+) detected using HPV DNA analysis with partial genotyping as primary screen test followed by cervical cytology and immunocytochemistry as triage tests
Time frame: Detected on histology biopsy at colposcopy after initial HPV screening with simultaneous cytology and immunocytochemistry testing
Number of women with CIN2+ detected using HPV DNA analysis with partial genotyping that is associated with HPV types 16, 18, 16 and/or 18, only other high risk types
Time frame: Detected on histology biopsy at colposcopy after initial HPV screening with simultaneous cytology and immunocytochemistry testing
Started Dec 2016 (actual). Primary completion is estimated for Dec 2038, 264 months after the start.
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University of Pretoria