Immuno-molecular Approaches for Non-invasive Diagnosis of Prostate Cancer (PROSTA-PAP)
Non-invasive Isolation and Characterization of Prostate Tumor Cells for Prostate Cancer Diagnosis
研究概览
详细说明
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.
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名：Marie BENHAMMANI-GODARD
- 电话号码：0033158411190
- 邮箱：marie.godard@aphp.fr
研究联系人备份
- 姓名：Julien ANRACT, MD
- 电话号码：+ 33(0)1 58 41 33 55
- 邮箱：julien.anract@aphp.fr
学习地点
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Paris、法国、75014
- 招聘中
- Cochin Hospital
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接触：
- Julien ANRACT, MD
- 电话号码：+ 33(0)1 58 41 33 55
- 邮箱：julien.anract@aphp.fr
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接触：
- Laura Nalleli GARRIDO CASTILLO, MSc
- 电话号码：00 33 1 40 61 56 06
- 邮箱：laura.garrido@rarecells.com
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Confirmed diagnosis group
Patients with a diagnosis of prostate cancer (metastatic or advanced) before prostatectomy.
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临床资料
Results obtained by biopsy and MRI results.
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Pre-diagnosis group
Patients undergoing prostate biopsy in the context of prostate cancer diagnosis: PSA increases, and / or abnormal digital rectal examination (DRE) and / or an MRI detected signal.
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临床资料
Results obtained by biopsy and MRI results.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Presence and number of prostate tumour cells in biological samples
大体时间：One month after biopsy or until the histological diagnosis will be obtained
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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
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One month after biopsy or until the histological diagnosis will be obtained
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合作者和调查者
调查人员
- 学习椅：Patrizia PATERLINI-BRECHOT, MD, PhD、INSERM and Rarecells Diagnostics
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
临床资料的临床试验
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Beth Israel Deaconess Medical CenterBrigham and Women's Hospital; Clinical Innovations, LLC招聘中
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Steno Diabetes Center CopenhagenUniversity of Southern Denmark; Steno Diabetes Center Sjaelland主动，不招人
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Royal Brompton & Harefield NHS Foundation TrustMedical Research Council; The Hillingdon Hospitals NHS Foundation Trust终止
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Jaeb Center for Health ResearchJDRF Artificial Pancreas Project完全的
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University of NottinghamEnhanced Recovery After Surgery Group (part of ESPEN)完全的