Interest of Circulating Tumor DNA in Digestive and Gynecologic/Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- To assess the prognostic impact of ctDNA (mortality) in digestive and gynecological / breast cancers.
研究概览
简要总结
Circulating tumor DNA (ctDNA) offers the possibility of accessing the tumor genome from circulating blood through a simple blood test. It is currently used for diagnostic, prognostic and predictive purposes of response or resistance to oncological treatments. These advances in ctDNA have been made possible by major developments in molecular biology techniques in recent years, as the detection of ctDNA requires very sensitive techniques such as Next Generation Sequencing (NGS).
CtDNA overcomes this problem of very limiting tumor heterogeneity during a solid biopsy. All of these applications make circulating DNA an increasingly essential tool in the management of cancer patients. The studies are currently in most cases on small numbers and are retrospective.
In addition, exosomes are also a biomarker of the future that can also be detected in the bloodstream . Exosomes are nanovesicles 50 to 200 nm in diameter released into the extracellular environment via the endosomal pathway by fusion with the plasma membrane. They are very informative since they transport tumor genetic material in the form of DNA, mRNA and miRNA, but also adhesion proteins, immunostimulatory molecules and cytoskeleton, enzymes and Heats shock proteins ( HSP).
The aim of the ADIGYN study is to set up a large prospective cohort to assess the diagnostic, prognostic and predictive impact of ctDNA and exosomes in digestive and gynecological / breast cancers. From the circulating DNA, we characterize the ActDNA on the molecular level thanks to the study of different point mutations usually used but also of new described mutations having a therapeutic impact and the search for other genetic alterations having an impact on the therapeutic strategy (such as microsatellite instability) or the study of exosomes and their composition. To assess resistance to oncological treatments, ctDNA will be analyzed at the start of treatment, during treatment, during progression and / or relapse and also during monitoring or treatment break
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Digestive or gynecological / breast cancer proven or suspected, requiring oncological treatment (chemotherapy or immunotherapy)
- •Major patient
- •Patients benefiting from a Social Security scheme or benefiting through the intermediary of a third party
- •Information note and collection of non-opposition after clear and fair information about the study
排除标准
- •Linguistic or psychological refusal or inability to understand and / or sign the information and no-objection note
- •History of a cancer other than that allowing inclusion in the 5 years preceding inclusion
结局指标
主要结局
To assess the prognostic impact of ctDNA (mortality) in digestive and gynecological / breast cancers.
时间窗: Through study completion, an average of 12 months
Correlation between ctDNA and overall survival
次要结局
- Evaluate the prognostic impact of exosomes and their composition(Through study completion, an average of 12 months)
- Evaluate the possibility of detecting certain molecular alterations using ctDNA and exosomes(Through study completion, an average of 12 months)
- Evaluate the diagnostic value of ctDNA and exosomes(Through study completion, an average of 12 months)
- Evaluate the predictive benefit of response / resistance to ctDNA and exosome treatments(Through study completion, an average of 12 months)