Molecular Triage in Cervical Cancer Prevention: The Tlaxcala Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100,000
- 试验地点
- 1
- 主要终点
- Histologically confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+)
研究概览
简要总结
While there is broad consensus that HR-HPV detection is the best available primary screening test, there is no agreement about the most efficient and reliable triage procedure for HR-HPV positive women. Transient HR-HPV infections are very common, and the vast majority of these infections spontaneously regress after a year or two. Only a small fraction of cases will lead to persistent infection responsible for cervical neoplasia. The FRIDA Study is a large, population-based study that was designed to evaluate the performance and cost-effectiveness of different triage strategies for hrHPV-positive women in Mexico.
详细描述
The target population is over <100,000 women aged 30 to 64 years who attend the Cervical Cancer Screening Program in 100 health centers in the state of Tlaxcala, Mexico. All women will be evaluated to determine hrHPV infection using the Cobas® 4800 HPV test. Triage strategies will be performed as reflex tests in all hrHPV-positive participants: HPV-16/18/45 genotyping, detection of the E6 oncoprotein of HPV-16/18, cytology, and immunocytochemistry using p16INK4a/Ki67. Women with at least one positive triage test will be referred for colposcopy evaluation, where a minimum of four biopsies and an endocervical sample are systematically collected. Histological confirmation will be performed by a standardized panel of pathologists.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 30 to 64
- •Residents of the municipalities included in Sanitary Jurisdiction No. 1 of Tlaxcala.
排除标准
- •Pregnant or hysterectomized women
- •Legally disabled women unable to give verbal informed consent required by the study protocol
- •Women who do not wish to participate in the present study
结局指标
主要结局
Histologically confirmed cervical intraepithelial neoplasia grade 2 or worse (CIN2+)
时间窗: 36 months
All women will be colposcopically evaluated in order to rule out any clinically evident invasive cancer. In cases of invasive cancer, patients will be referred to onco-gynecology services immediately. Before biopsy collection, endocervical sampling is performed using an Endocervex Brush®. A minimum of four biopsies are collected, at least one per quadrant, from the more suspicious area on cervical transformation zone. Histological evaluation of all samples (biopsies and/or endocervical curettage samples) will be evaluated for final diagnosis and confirmation of CIN2+ cases by two pathologists according to Mexico's Cervical Cancer Screening Programme's guidelines. An external expert-pathologist, will resolve discrepancies and render a final decision.
次要结局
未报告次要终点
研究者
Eduardo Cesar Lazcano Ponce
Eduardo Lazcano-Ponce, MD, DSc
Instituto Nacional de Salud Publica, Mexico