Screening Study for Cervical Pre-cancer and Cancer Prevention in South African Women.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2038-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cervical Cancer High Grade Sil CIN2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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HIV pos

those who serologically tested positive for HIV

Screening

Intervention Type OTHER

Cervical specimen obtained using speculum examination and cervical collection bush.

Colposcopy

Intervention Type OTHER

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.

LLETZ

Intervention Type PROCEDURE

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).

HIV neg

those who serologically tested negative for HIV

Screening

Intervention Type OTHER

Cervical specimen obtained using speculum examination and cervical collection bush.

Colposcopy

Intervention Type OTHER

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.

LLETZ

Intervention Type PROCEDURE

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).

HIV unk

those with no available serological test for HIV

Screening

Intervention Type OTHER

Cervical specimen obtained using speculum examination and cervical collection bush.

Colposcopy

Intervention Type OTHER

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.

LLETZ

Intervention Type PROCEDURE

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).

Interventions

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Screening

Cervical specimen obtained using speculum examination and cervical collection bush.

Intervention Type OTHER

Colposcopy

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.

Intervention Type OTHER

LLETZ

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).

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes