Non-invasive Isolation and Characterization of Prostate Tumor Cells for Prostate Cancer Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Presence and number of prostate tumour cells in biological samples
研究概览
简要总结
The purpose of this study is to isolate and characterize tumor cells non-invasively from biological samples in patients with prostate cancer and demonstrate the ability to identify the presence and number of tumor cells before prostate biopsy.
详细描述
Prostate cancer is one of the most frequently diagnosed cancers and a leading cause of cancer death in men worldwide. Existing methods of diagnosis and monitoring of prostate cancer are inadequate due to their invasiveness, inaccuracy, cost, access uneven, etc., making difficult the diagnosis and patient's follow up. New techniques and methods are necessary to improve diagnosis.
Biological liquids might represent an attractive target to isolate prostate tumour cells for these purposes. In recent years, several studies have been carried out with the aim of reducing and / or avoiding the limits of sensitivity and specificity of current methods of screening for prostate cancer and thus obtain new biomarkers for the diagnosis and / or non-invasive monitoring.
However, due to technical and technological difficulties few studies have been performed to investigate the non-invasive isolation and direct analysis of tumour cells. Our project is therefore an innovative project which aims to study a new approach for the early diagnosis of prostate cancer, with better sensitivity and specificity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Patients with a diagnosis of localized or metastatic prostate cancer.
- •No prior or other oncological treatment.
- •Patients undergoing prostate biopsy in the context of prostate cancer diagnosis.
- •Patients with an elevation of PSA (Prostate Specific Antigen), an abnormality on the rectal examination and / or an MRI signal motivating a prostate biopsy,
- •Patients informed and not opposed to participating in the research
排除标准
- •Patients not affiliated with French social security.
- •Patients unable to understand the protocol.
- •Patients diagnosed with another type of cancer within the past 5 years.
- •Patients prostatectomized and/or treated for prostate cancer.
- •Patients who wear a bladder catheter
- •Patients under guardianship or curatorship
- •Patients under AME
结局指标
主要结局
Presence and number of prostate tumour cells in biological samples
时间窗: One month after biopsy or until the histological diagnosis will be obtained
Cell enrichment will be carried out using the ISET® (Isolation by SizE of Tumor/Trophoblastic cells) technology. Identification will be performed by different spectroscopic and/or immune-molecular and/or cytological approaches
次要结局
未报告次要终点