Study on the Contribution of the Genetic Tumor Profile Obtained by Circulating Tumor DNA Analysis in the Multidisciplinary Molecular Biology Meeting of Eastern PACA
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Sensitivity of liquid biopsy versus solid biopsy (gold standard)
研究概览
简要总结
This study will evaluate the diagnostic performance of liquid biopsy for identifying molecular abnormalities among patients managed by the Multidisciplinary Molecular Biology Meeting. The gold standard considered in this study is the solid biopsy.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years old.
- •Advanced-stage malignant solid tumor managed in a non-curative context.
- •Patient eligible for Multidisciplinary molecular biology meeting with available archived tumor material (frozen or FFPE block, less than 5 years old) or a biopsiable tumor lesion.
- •Patient able to read, write, and understand the French language.
- •Patient has read the information sheet and signed the informed consent.
- •Patient has social security coverage.
排除标准
- •Previous or concurrent cancer diagnosed or treated within the last 5 years, except for in situ carcinoma of the cervix, basal cell or squamous cell carcinoma of the skin, and adequately treated in situ carcinoma of the bladder.
- •Severe or uncontrolled systemic disease.
- •Any condition which, in the investigator's judgment (geographical, social, or psychological factors, etc.), makes the patient unable to comply with study follow-up and procedures.
- •Patient considered a vulnerable person; vulnerable persons are defined in Articles L1121-5 to L1121-8:
- •Pregnant women, women in labor, and breastfeeding mothers,
- •Persons deprived of liberty by judicial or administrative decision, individuals hospitalized without consent under Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8,
- •Persons admitted to a healthcare or social institution for reasons other than research,
- •Adults unable to give their consent.
研究组 & 干预措施
Experimental
For this study, the included patients will have a blood sample (36 mL) taken. Molecular analyses will be performed on this blood sample (liquid biopsy) in addition to the molecular analyses routinely conducted on the tumor sample (solid biopsy).
干预措施: Blood sample taken for the liquid biopsy (Procedure)
结局指标
主要结局
Sensitivity of liquid biopsy versus solid biopsy (gold standard)
时间窗: 1 month
The primary endpoind is the sensitivity of liquid biopsy versus solid biopsy as the gold standard for detecting genomic alterations evaluated in the studied gene panel. The panel will consist of 70 genes common to the PanoraMix panels (125 genes, FFPE) and Avida (104 genes, cpDNA).
次要结局
- Specificity of liquid biopsy versus solid biopsy (gold standard)(1 month)
- Failure rate of molecular screening(1 month)
- Clinical factors predictive of the sensitivity of liquid biopsy.(1 month)
- Rate of unexploitable results(1 month)
- Time required to obtain each analysis(1 month)