Clinical trial NCT02956031: Screening Study for Cervical Pre-cancer and Cancer Prevention in South African Women.
Official title: Primary HPV Screening as an Indicator of Cervical Pre-invasive and Invasive Neoplasia in HIV-positive and -Negative Southern African Women
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer
High Grade Sil
CIN2
Keywords: cancer prevention
cervical screening
cervical cancer
cervical disease
cervical neoplasm
HPV testing
immunocytochemistry
triage techniques
Lead sponsor: University of Pretoria
Sponsor class: OTHER
Collaborators: name: University of Stellenbosch
First posted: 2016-11-04
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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

Primary outcomes:
measure: 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
timeFrame: Detected on histology biopsy at colposcopy after initial HPV screening with simultaneous cytology and immunocytochemistry testing
Secondary outcomes:
measure: 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
timeFrame: Detected on histology biopsy at colposcopy after initial HPV screening with simultaneous cytology and immunocytochemistry testing
Other outcomes:
Locations:
city: Pretoria
country: South Africa
facility: Steve Biko Academic Hospital
state: Gauteng
Study officials:
affiliation: University of Pretoria
name: Greta D Dreyer, PhD
role: PRINCIPAL_INVESTIGATOR
References: