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

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ClinicalTrials.gov Identifier: NCT02956031
Recruitment Status : Recruiting
First Posted : November 4, 2016
Last Update Posted : October 26, 2018
Sponsor:
Collaborator:
University of Stellenbosch
Information provided by (Responsible Party):
Professor Greta Dreyer, University of Pretoria

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.


Condition or disease Intervention/treatment
Cervical Cancer High Grade Sil CIN2 Other: Screening Other: Colposcopy Procedure: LLETZ

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 3 Months
Official Title: Primary HPV Screening as an Indicator of Cervical Pre-invasive and Invasive Neoplasia in HIV-positive and -Negative Southern African Women
Study Start Date : December 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
HIV pos
those who serologically tested positive for HIV
Other: Screening
Cervical specimen obtained using speculum examination and cervical collection bush.

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.

Procedure: 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).

HIV neg
those who serologically tested negative for HIV
Other: Screening
Cervical specimen obtained using speculum examination and cervical collection bush.

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.

Procedure: 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).

HIV unk
those with no available serological test for HIV
Other: Screening
Cervical specimen obtained using speculum examination and cervical collection bush.

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.

Procedure: 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).




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956031


Contacts
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Contact: Greta Dreyer, PhD +(27) 12 354 3900 greta.dreyer@up.ac.za
Contact: Cathy Visser, MSc +(27) 12 354 3900 cathy.visser@up.ac.za

Locations
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South Africa
Steve Biko Academic Hospital Recruiting
Pretoria, Gauteng, South Africa
Contact: Cathy Visser, MSc    +27 12 354 3900    visser.cathy@gmail.com   
Principal Investigator: Leon C Snyman, MMedO&G;FCOG         
Sponsors and Collaborators
University of Pretoria
University of Stellenbosch
Investigators
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Principal Investigator: Greta D Dreyer, PhD University of Pretoria

Additional Information:

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Responsible Party: Professor Greta Dreyer, Professor, University of Pretoria
ClinicalTrials.gov Identifier: NCT02956031     History of Changes
Other Study ID Numbers: DiaVACCS
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018
Keywords provided by Professor Greta Dreyer, University of Pretoria:
cancer prevention
cervical screening
cervical cancer
cervical disease
cervical neoplasm
HPV testing
immunocytochemistry
triage techniques
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female