An interventional study of HPV Test in Cervical Cancer, sponsored by Prof. Patrick Petignat. Completed at 1 site in Switzerland. Open to female participants aged 30 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-15.
Sponsored by Prof. Patrick Petignat · Not applicable, Interventional, and Prevention
In sub-Saharan Africa, cervical cancer is the leading cause of cancer death among women because of the difficulty in implementing screening programs. The main obstacles in these countries are poverty, lack of healthcare infrastructures and trained practitioners. With the availability of new technologies, researchers are looking for new strategies adapted to low- and middle-income countries to identify cervical precancerous lesions.
Current evidence shows that Human Papilloma Virus (HPV) testing is more effective than cytology (Pap smear) for cervical cancer screening in resource-limited settings. Indeed, the GeneXpert® HPV test offers the opportunity to prevent cervical cancer (CC) in a single visit: rapid detection of high-risk HPV (HPV) infection followed by same day treatment of HPV-positive women during the same visit (screen-and-treat approach).
However only a small proportion of HPV-positive women will develop cervical (pre)cancer, making it important to select those to treat. This triage can be achieved by colposcopy, cytology and visual inspection after application of acetic acid (VIA). Though VIA is the triage test recommended by WHO for resource-limited countries, it has not yet been widely assessed in sub-Saharan Africa (SSA).
The main objective of the investigators is to assess the performance of HPV-test followed by Visual Inspection after application of Acetic acid and Lugol's iodine VIA/VILI to detect cervical precancerous lesions in a screen-and-treat strategy in Cameroon (sub-Saharan Africa) where there is no cervical cancer-screening program.
The investigators organized a successful free screening campaign in Cameroon in 2015 that allowed to identify the expectations of women and their eagerness to benefit from prevention of gynecological cancers and sexually transmitted diseases.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's enrollment of 4,473 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Prof. Patrick Petignat is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Diagnostic Test: HPV Test
Vaginal specimens for HPV test will be collected by participants themselves using flocked swabs after explanations by co-investigators. Two transport mediums will be used for those self-collected vaginal samples: NaCl 0.9%.
Also known as: VIA/VILI,, Pap smear,, Cervical biopsy, ECC
Sensitivity and specificity of HPV test followed by VIA/VILI to detect cervical precancerous lesions in sub-Saharan Africa using histology as gold standard
VIA/VILI is assessed by pelvic examination and Sensitivity and specificity are measured by using histology as gold stantard
Time frame: 3 - 5 years
Prevalence of HPV infection
HPV self-test analysed by GeneXpert machine
Time frame: 3 - 5 years
Prevalence of cervical pre-cancer and cancer among Cameroonian women
Histological analyses of cervical biopsies and endocervical brushing
Time frame: 3 - 5 years
HPV clearance
Measured by self HPV performed at 6 and 12 months follow up
Time frame: 3 - 5 years
Persistance of CIN2+ disease at the 12-month follow-up
Histological analyses of cervical biopsies and endocervical brushing
Time frame: 3 - 5 years
Provide teaching material for professional training on cervical cancer prevention through VIA/VILI (cervical images database)
images database
Time frame: 3 - 5 years
Acceptability rate of self-HPV test and cervical cancer screening procedures
To assess the acceptability of self-HPV, patients complete a questionnaire comprising different questions about the collection device (embarassment, comfort, anxiety and confidence about the test). Likert Scale 4 points : 1 (not at all) to 4 (very).
Time frame: 3 years
Proportion of side effects and complications after thermoablation or LEEP
questionnaire
Time frame: 3 - 5 years
VIA test-positive rate (HPV-positive women);
VIA/VILI is assessed by pelvic examination
Time frame: 3 - 5 years
VIA test-positive rate after 1- year follow-up of VIA-negative tests
VIA/VILI is assessed by pelvic examination
Time frame: 3 - 5 years
Thermal ablation efficacy rate
Thermal ablation efficacy rate will be assessed according to the biopsy proven CIN2+ rate after thermoablation treatment at the 6 and 12-month follow-up. The absence of CIN2+ will determine the success of the treatment in a patient who previously had a CIN2+ lesion. Adverses event : bleeding, complications, hospitalization
Time frame: 3 - 5 years
Acceptability rate of thermoablation
To assess the acceptability of thermoablation, patients completed a questionnaire comprising different questions about treatment tolerance, pain and following side effects. Respondent were invited to rate answers on a likert scale of 1 (no accpetability) to 4 (high acceptability)
Time frame: 3 years
Sexual dysfunction score, score of anxiety and method of contraception after screening procedures,
SF12, Asex, STAI 6 Y-form
Time frame: 2 years
Number of women screened with and without community health care workers.
community health workers registre
Time frame: 2 years
Increase awareness on gynecological pathologies, including cervical cancer, sexually transmitted diseases and HIV, vaginal fistula in the community of the study area,
questionnaire
Time frame: 3-5 years
Plan to share: Undecided
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Prof. Patrick Petignat