CompletedNot Applicable

Cervical Cancer Screening of Postmenopausal Women in Low- and Middle-income Countries Using HPV Self-sampling and Triage by Genotyping and Cytology

Cameroon500 participantsStarted 2024-06-01

Plain-language summary

Cervical cancer remains a major cause of mortality in low- and middle-income countries, especially among women aged 50 years and older who are often under-screened. In post-menopausal women, the transformation zone is frequently not visible, which makes visual inspection with acetic acid (VIA) less reliable and limits access to adequate screening. Human papillomavirus (HPV) self-sampling offers a simple and acceptable primary screening method, but effective triage options for HPV-positive women in this age group remain limited. This study aims to evaluate the feasibility and diagnostic performance of a screening strategy based on HPV self-sampling followed by Pap cytology triage among HPV-positive women aged 50 to 65 years in Cameroon. Approximately 500 women will be invited to perform self-HPV testing at the Mifi District Hospital. HPV-positive women will undergo Pap cytology, endocervical brushing and digital cervicography, and eligible participants will receive treatment with thermal ablation at Bafoussam Regional Hospital. Follow-up at 12 months will include repeat HPV testing, cytology, and endocervical brushing. The primary outcome is the diagnostic accuracy of HPV + cytology triage for detecting CIN2+. Secondary outcomes include prevalence of high-risk HPV, treatment outcomes, acceptability, and adherence to follow-up.

Who can participate

Age range

50 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women aged 50 to 65 years old; * Ability to understand study procedures and accepting voluntarily to participate by signing an informed consent form (ICF). Exclusion Criteria: * Women who is pregnant; * Women with a condition that interfere with visualization of the cervix; * Women with vaginal bleeding outside the menstrual period; * Women who have had a total hysterectomy; * Women with a history of cervical cancer; * Women screened for cervical cancer in the last 5 years or in the last 3 years if HIV-positive; * Women in the terminal phase of an illness.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sensitivity and specificity of HPV test followed by cytology to detect cervical precancerous lesions in sub-Saharan Africa using histology as gold standard

Timeframe: 1 year

Trial details

NCT IDNCT07244315

SponsorUniversity Hospital, Geneva

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Cervical Cancer Screening trials