Epidemiologic and Molecular Features of Cervical Cancer in Nigeria - Project Itoju (Care)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,466
- 试验地点
- 1
- 主要终点
- Sensitivity of triage methods
研究概览
简要总结
Background:
- Cervical cancer is caused by persistent infection of the lining of the cervix with some kinds of human papillomaviruses (HPV). These HPV infections are distantly related to the viruses that cause warts on the skin. Like common wart viruses, most women who have cervical infections with HPV resolve the infections within 2 years without any need for treatment. Cervical infections that do not go away may cause disease that can turn into cancer after many years.
- Only one study has been done in Nigeria to learn how many women have HPV infection. The results of the study differed from most other studies in the world because older women were much more likely to be infected. This study with learn whether the results found in the previous study are true in Irun also, the site of the current study.
Objectives:
- To examine the age distribution of HPV infection and relationship to cancer of the cervix among Nigerian women.
- To understand how different screening methods, including HPV testing, could best reduce the risk of cervical cancer in Nigerian women.
Eligibility:
- Women residing in Irun, Nigeria, who are 15 years of age or older.
Design:
- Participants complete a brief questionnaire related to demographics, household and living conditions and a longer survey with questions related to reproductive history, family history, illnesses, stressful life events and sexual history (U. of Michigan collaboration).
- Participants have a cervical examination, HPV test, Pap test and blood test.
- Women whose tests show they are infected with HPV or have cervical disease will do the following:
- see a doctor and have cervical biopsies of all white abnormal areas (removal of a small tissue sample from the cervix)
- have photographs of the cervix taken
- have a cervical scraping for a new kind of HPV test.
- Some women with normal test results are also asked to see a doctor to check the validity of the testing
- Women with cervical disease receive treatment by a specialist and remain in the program until treatment is successfully completed or a final diagnosis is reached.
- Participants may be contacted for followup up to 5 years after the final diagnosis is made.
详细描述
BACKGROUND: Cervical cancer, caused by persistent infection with approximately 15-20 genotypes of carcinogenic human papillomavirus (HPV) infection, is the second leading cause of female cancer. Cytology (Pap smears) and the new HPV vaccines are not widely available in poor regions. Immediate treatment of HPV-infected older women by cryotherapy might have greater impact.
Although the same HPV types cause cervical cancer everywhere, and the same stages (infection, persistence vs. clearance, progression to precancer, and invasion) typify cervical carcinogenesis, the patterns of age-specific prevalence of HPV vary widely. These patterns are important for secondary prevention strategies relying on HPV DNA testing.
In many regions, including the US, HPV infections appear as classical sexually-transmitted agents, with peak cervical DNA prevalence at young ages (approximately 20) and low prevalence at older ages. However, in Nigeria, HPV prevalence is high (greater than or equal to 15%) at all ages according to the one study performed in urban Ibadan by Franceschi s group at IARC (n=932 women). This pattern is very uncommon. High prevalence at all ages would preclude use of HPV testing in low-cost strategies, due to poor positive predictive value. One possibly relevant element is the marital structure in Nigeria; a man often has multiple wives.
OBJECTIVES: The major objectives are: 1) To estimate age-specific HPV prevalences in Irun, Nigeria; 2) To investigate epidemiologic risk factors for HPV and cervical intraepithelial neoplasia in this population; 3) To examine the performance of screening options; 4) To assess the correlation of HPV among co-wives, comparing households with multiple wives with those with single wives; and 5) To validate the performance of rapid HPV, an inexpensive HPV test designed for public-sector use in settings like Irun.
ELIGIBILITY: All non-pregnant women aged 15+, without hysterectomy, will be eligible if they can provide written informed consent. Unmarried women less than 21 will be enrolled only with parental consent. Sexually active women will be examined and asked for cervical specimens; self-reported virginal women will be asked for a 10-ml blood sample only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Sensitivity of triage methods
时间窗: cross-sectional
Cervical Histopathology
次要结局
未报告次要终点
