Promoting Comprehensive Cervical Cancer Prevention and Better Women Health in Cameroon
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cervical Cancer
- Sponsor
- Prof. Patrick Petignat
- Enrollment
- 4473
- Locations
- 1
- Primary Endpoint
- Sensitivity and specificity of HPV test followed by VIA/VILI to detect cervical precancerous lesions in sub-Saharan Africa using histology as gold standard
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Prof. Patrick Petignat
Director of the gynecology departement
University Hospital, Geneva
Eligibility Criteria
Inclusion Criteria
- •Women aged 30-49 years, able to comply with the study protocol
Exclusion Criteria
- •Pregnancy
- •Previous total hysterectomy
- •Conditions impairing examination of the cervix
Outcomes
Primary Outcomes
Sensitivity and specificity of HPV test followed by VIA/VILI to detect cervical precancerous lesions in sub-Saharan Africa using histology as gold standard
Time Frame: 3 - 5 years
VIA/VILI is assessed by pelvic examination and Sensitivity and specificity are measured by using histology as gold stantard
Secondary Outcomes
- Provide teaching material for professional training on cervical cancer prevention through VIA/VILI (cervical images database)(3 - 5 years)
- Acceptability rate of self-HPV test and cervical cancer screening procedures(3 years)
- Thermal ablation efficacy rate(3 - 5 years)
- Sexual dysfunction score, score of anxiety and method of contraception after screening procedures,(2 years)
- VIA test-positive rate after 1- year follow-up of VIA-negative tests(3 - 5 years)
- Increase awareness on gynecological pathologies, including cervical cancer, sexually transmitted diseases and HIV, vaginal fistula in the community of the study area,(3-5 years)
- Prevalence of HPV infection(3 - 5 years)
- Prevalence of cervical pre-cancer and cancer among Cameroonian women(3 - 5 years)
- Proportion of side effects and complications after thermoablation or LEEP(3 - 5 years)
- Acceptability rate of thermoablation(3 years)
- Number of women screened with and without community health care workers.(2 years)
- HPV clearance(3 - 5 years)
- Persistance of CIN2+ disease at the 12-month follow-up(3 - 5 years)
- VIA test-positive rate (HPV-positive women);(3 - 5 years)