Promoting Comprehensive Cervical Cancer Prevention and Better Women Health in Cameroon
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,473
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity of HPV test followed by VIA/VILI to detect cervical precancerous lesions in sub-Saharan Africa using histology as gold standard
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 30-49 years, able to comply with the study protocol
排除标准
- •Pregnancy
- •Previous total hysterectomy
- •Conditions impairing examination of the cervix
结局指标
主要结局
Sensitivity and specificity of HPV test followed by VIA/VILI to detect cervical precancerous lesions in sub-Saharan Africa using histology as gold standard
时间窗: 3 - 5 years
VIA/VILI is assessed by pelvic examination and Sensitivity and specificity are measured by using histology as gold stantard
次要结局
- 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)
研究者
Prof. Patrick Petignat
Director of the gynecology departement
University Hospital, Geneva