Improving Cervical Cancer Prevention Among HIV-Infected Women Using Novel HPV Based Biomarker Assays
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Cervical Intraepithelial Neoplasia Grade II or more severe
研究概览
简要总结
Background:
- Cervical cancer is a major cause of cancer deaths among women. Most cases of cervical cancer are caused by the human papillomavirus (HPV). HPV is more common in women who have the human immunodeficiency virus (HIV). India has one of the highest rates of women who have both cervical cancer and HIV infection.
- Cervical cancer can be discovered in early stages by screening for HPV infection. Researchers want to compare new cervical cancer screening tests for HIV-infected women. They also want to know more about how HPV can lead to cervical cancer in HIV-infected women. To do so, they will hold a study to screen HIV-infected women in India.
Objectives:
- To improve cervical cancer screening methods in HIV-infected women in India.
Eligibility:
- Women at least 18 years of age who have HIV infection.
- Participants will be recruited from HIV-focused health care clinics in Pune and Chennai, India.
Design:
- Participants will have a physical exam and medical history. They will provide a urine sample and proof of HIV infection.
- Participants will have a gynecological exam. This will involve a pelvic exam and Pap smear to collect cells for study. It will also involve a cervical exam to look for precancerous cells. Cervical tissue may be collected.
- Participants will also provide a blood sample for testing.
- Participants will return in 2 weeks for the test results. If there are signs of precancerous or cancer cells, participants will be referred to a doctor for treatment.
详细描述
Background:
While HPV DNA testing is a highly sensitive screening method for cervical cancer, it cannot differentiate between the majority of benign infections and few persistent infections linked to cervical precancer. Given the high prevalence of carcinogenic HPV DNA and higher risk for cervical precancer and cancer among HIV-infected women, there is a substantial need for screening tests that are both adequately sensitive as well as specific, so as to maximize detection while reducing false-positive referrals. Furthermore, the unique immunological milieu in HIV-infected women presents significant opportunities to study natural history of HPV-mediated cervical oncogenic process in the context of immunosuppression.
Objectives and Methods:
The primary objective is to evaluate the clinical performance of two novel biomarker assays for detection of histologically-confirmed cervical intraepithelial neoplasia grade 2/3 or more severe (greater than or equal to CIN2 and greater than or equal to CIN3) among HIV-infected women. These tests include: (i) immunocytostaining by p16(INK4a)/Ki-67 (biomarkers correlated with the oncogenic transformation of cervical cells following persistent carcinogenic HPV infection) and (ii) testing for HPV E6/E7 mRNA (expressed during progression of a transient to a transforming HPV infection). Secondary objectives include studying the association of risk factors and biomarkers with specific HPV genotypes and studying the interaction of HIV and HPV in cervical disease categories and in the context of immunosuppression.
Eligibility:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older 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
Cervical Intraepithelial Neoplasia Grade II or more severe
时间窗: At enrollment
Cervical Intraepithelial Neoplasia Grade II or more severe
次要结局
未报告次要终点