Oncoliq: Test for Early Breast Cancer Detection.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- miRNA levels in plasma
研究概览
简要总结
Oncoliq is a novel early breast cancer detection test based on liquid biopsies and microRNAs. This innovative test will allow improving the accuracy of cancer detection which will impact on health, reducing the patient mortality and health costs.
To develop this test, it has been finished the preclinical PHASE I: in laboratory animals; PHASE II: exploratory clinical phase for the discovery of candidate biomarkers in breast cancer patients and PHASE III: clinical validation of biomarkers showing that Oncoliq has 91% of sensitivity.
Currently it is been setting up a "pilot test" for breast cancer to enrol 500 woman volunteers without previous cancer diagnosis that go to the annual medical control. The results of the pilot test will give the accuracy for early breast cancer detection.
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
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women patients performing gynecological control
- •Between 50-70 years old
- •Without personal history of oncological disease
- •Informed consent signed
排除标准
- •Patients who don´t meet the inclusion criteria.
- •Active infection with SARS-CoV-2 (COVID-19).
结局指标
主要结局
miRNA levels in plasma
时间窗: Day 1
miRNA levels in plasma will be determined by RT-qPCR.
次要结局
未报告次要终点
研究者
Adriana De Siervi
Ph.D.; Principal Investigator
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich