Determination of the Feasibility of Tumoural Somatic Mutations Detection in Blood of Patients With Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Concordance between DNA extracted from tumour tissue and cfDNA extracted from plasma (SNV, indels)
研究概览
简要总结
BOVARY-Pilot is a monocentric prospective transversal pilot study with a total duration of 6 months. The purpose of this study is to determine the feasibility of detecting somatic tumor mutations in the blood of patients with ovarian cancer in order to determine whether a blood test can replace a tissue biopsy to prescribe a personalized treatment. The method will consist of a single blood sample during the patient's visit and prior to the establishment of any newly diagnosed cancer treatment. The concordance of somatic mutations (SNV) found in tissue and in cell-free DNA (cfDNA) extracted from blood will then be compared
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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 ≥ 18 years
- •Patient with stage III to IV non-treated high grade ovarian cancer or recurrent high grade ovarian cancer
- •Adequate haemoglobin rate ≥ 9 g/dL
- •Patient who can benefit from an additional blood sample of 20ml. The total volume of each sample meets with the indications of the Order in force establishing the list of researches mentioned in 2 ° of Article L. 1121-1 of the Public Health Code.
- •Availability of tumor samples from biopsy or surgery
- •Patient affiliated to a social security scheme
- •Ability to provide written informed consent
排除标准
- •Any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study
- •Contraindication to a blood sample of 20 mL
- •Pregnant or breast-feeding women
- •Ongoing treatment for the newly diagnosed cancer or the recurrence
- •Patient pre-treated with poly-ADP-ribose-polymérase-1 (PARP) Inhibitors
- •Patient under guardianship or curatorship or deprived of liberty.
结局指标
主要结局
Concordance between DNA extracted from tumour tissue and cfDNA extracted from plasma (SNV, indels)
时间窗: 1 day (samples will be analyzed in batch at the end of inclusions)
Number of patients with detected punctual somatic mutations (SNVs and indels of BRCA1/2 and genes involved in HRD) concordance between DNA extracted from tumour tissue and cfDNA extracted from plasma
次要结局
- Concordance between DNA extracted from tumour tissue and cfDNA extracted from plasma (large rearrangements, LOH, CNV)(1 day (samples will be analyzed in batch at the end of inclusions))