Development of the PRIME Test for the Identification of Prostate Cancer Patients' Biomarkers Through Non-invasive Liquid Biopsies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 4
- 主要终点
- Quantification of circulating tumor DNA (ctDNA) in the plasma
研究概览
简要总结
The study aims to develop PRIME (PRostate cancer plasma Integrative Multi-modal Evaluation) liquid biopsy test and to implement its use to query prospectively collected samples in advanced prostate cancer (PCa) clinical trials and/or clinical settings. In order to maximise the utility of liquid biopsies for advanced PCa, PRIME is focused on the development of novel computational and sequencing approaches that integrate multiple information from plasma circulating elements: i) cell free DNA (cfDNA) gene mutation data with accurate quantitation of cfDNA structural genomic changes, ii) cfDNA genomic profiling with cfDNA methylation status, and iii) the information provided by extracellular vesicles (EVs) and EV-associated cargo (including DNA, RNA and proteins).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of prostate cancer
- •Eligible for prostate cancer pharmacological treatment
- •Given consent to study participation
排除标准
- •Histological diagnosis other than prostate cancer
结局指标
主要结局
Quantification of circulating tumor DNA (ctDNA) in the plasma
时间窗: From enrolment across different lines of treatment
Number of circulating tumor DNA (ctDNA) in the plasma
Quantification of the fraction of cfDNA hypo/hypermethylation
时间窗: From enrolment across different lines of treatment
Rate of cfDNA hypo/hypermethylation
Presence of recurrent somatic aberrations in ctDNA (such as loss of RB1, TP53, BRCA1/2, or AR amplification).
时间窗: From enrolment across different lines of treatment
Assessment (yes/no) of recurrent somatic aberrations in ctDNA (such as loss of RB1, TP53,
Presence of Copy Number Variants (CNVs) in ctDNA
时间窗: From enrolment across different lines of treatment
Assessment (yes/no) of Copy Number Variants (CNVs) in ctDNA
Identification of EV-associated biomarkers
时间窗: From enrolment across different lines of treatment
Assessment (yes/no) of EV-associated biomarkers
次要结局
未报告次要终点
研究者
Orazio Caffo
Director, Medical Oncology Unit
Santa Chiara Hospital