Clinical trial · Observational
Cervical Cancer Screening of Postmenopausal Women in Low- and Middle-income Countries Using HPV Self-sampling and Triage by Genotyping and Cytology
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer Screening | — | UNRESOLVED | — |
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| HPV Infections | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vaginal specimens for HPV test will be collected by participants themselves using flocked swabs after explanations by co-investigators. | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Women from the general population aged 50-65 years old
- description
- Women from the general population aged 50-65 years old eligible for screening in the West region of Cameroon. 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.
- interventionNames
- Diagnostic Test: Vaginal specimens for HPV test will be collected by participants themselves using flocked swabs after explanations by co-investigators.
Primary outcomes (1)
- measure
- 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
- description
- To determine the diagnostic performance of screening strategies using HPV testing with cytology triage and/or extended genotyping in women aged between 50 and 65 years for the detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+);
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available