Development and Validation of a Circulating Tumor DNA Detection Technique in Patients With Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Assessment and development of circulating tumor DNA detection techniques
研究概览
简要总结
Circulating tumor DNA detection and quantification in patients with ovarian cancer.
详细描述
Technique development:
In a first step, the different available techniques will be evaluated for specificity and sensibility using serial dilutions of cell lines with or without TP53 mutation.
Validation:
The tumor DNA detection rate will be estimated from patient's blood with ovarian cancer.
The investigators will study 25 patients to obtain at least 15 patients bearing a TP53 mutation that could be characterized in the primitive tumor or metastasis. With those 15 patients, the investigators will determine the most sensitive technique and the best cost/efficiency ratio.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Age > or = 18 years.
- •Patient with invasive ovarian cancer stage II to IV from FIGO classification.
- •Patient treated by surgery.
- •Patient with tumor or metastasis available for TP53 status characterization
- •Patient able to stand a blood collection.
- •Signed written informed consent approved by AFSSAPS and CPP.
排除标准
- •Patient without social protection / insurance.
- •Borderline ovarian tumor.
- •Non carcinoma ovarian tumor
- •Patient with invasive ovarian cancer 5 years before diagnosis
- •Current pregnancy and lactation.
- •All social, medical, psychological, situations making the study impossible.
- •Person deprived of liberty.
结局指标
主要结局
Assessment and development of circulating tumor DNA detection techniques
时间窗: 2 years
Quantification of circulating tumor DNA in blood samples. Results expressed in number of samples where circulating DNA is present.
次要结局
- Comparison of the detection techniques (PAP (pyrophosphorolysis activated polymerisation), BEAMing, NGS(Next sequencing generation) with regards to feasibility, robustness, sensitivity and cost.(2 years)