Diagnostic Performance Assessment of Qualitative Ifobt and Various Quantitative Ifobt Cut-off Points for Advanced Neoplastic Wound Screening in an Argentine Patient Cohort
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 630
- 试验地点
- 1
- 主要终点
- diagnostic performance
研究概览
简要总结
In Argentina, there is vast experience in qualitative iFOBT population screening that is part of the CRC Prevention and Early Detection National Program. The screening's cut-off point is at 50 ng/mL buffer. Its positivity rate for 2019 has been an average of 26.15%, over the double of the one reported in the international literature (7.5-11%) for this cut-off point (1). There are no studies that assess such technology and suggest an appropriate cut-off point for this population. The goal of this study is to assess the diagnostic performance of the qualitative iFOBT used in the present and the quantitative iFOBT with various cut-off points for advanced neoplastic wound screening (colorectal cancer and advanced adenoma) in an Argentine patient cohort.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •men and women aged 50-75
- •Hospital El Cruce's coverage area and
排除标准
- •those that have taken part in a previous VCC screening in the 5 past years or in a CRC screening program the year before the recruitment
- •personal history of colorectal cancer or inflammatory bowel disease, personal or family history of syndromes of predisposition to known cancers, or family history of colorectal cancer in a first-degree relative aged less than 60
- •those refuse to sign the consent form to take part in this study
结局指标
主要结局
diagnostic performance
时间窗: 2 years
To determine the diagnostic performance of the quantitative iFOBT with various cut-off points and the qualitative iFOBT, compared to the VCC, when detecting advanced colon neoplasms.
次要结局
- qualitative iFOBT positivity rate(2 years)
研究者
CECILIA CURVALE
Clinical Investigator
Hospital El Cruce