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临床试验/NCT02282644
NCT02282644已完成不适用

Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2014年9月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
2
主要终点
Risk of death according to positive makers

研究概览

简要总结

The recent data suggest that cancer cells at the origin of prostate cancer metastases can be detected in an early stage. Available techniques allow phenotypic analysis of cancer cells in circulating blood (cellsearch) or in marrow hematopoietic (flow cytometry). Pilot study on 180 patients infected by prostate cancer at all stage of disease, show that c-met marker , integrin alpha 2 and 6 expressed in marrow and quantified by flow cytometry were predictor of metastatic progress. In this new study the investigators will analyze antibody panel by cellsearch and flow cytometry on marrow sample of castration-Resistant prostate cancer patients.

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
Male
接受健康志愿者

入选标准

  • Histologically confirmed adenocarcinoma or prostate
  • Ongoing effective androgen deprivation therapy (testosterone ≤ 50 ng/mL)
  • Castration-Resistant prostate cancer patient : defined as a minimum of 3 rising PSA values assessed and/or radiological progress confirmed by RECIST and PCWG2
  • Patient who signed informed consent

排除标准

  • Severe disorders of coagulation
  • Major skin lesion on iliac crests
  • Allergies in local anesthetics
  • Psychological instability or psychiatric histories
  • Uncertain follow-up and distant residence
  • History of another invasive cancer and hematologic disease
  • Patient deprived of their freedom by court or administrative order
  • Revocation of consent

研究组 & 干预措施

CellSearch

Experimental

干预措施: Bone marrow sampling (Biological)

结局指标

主要结局

Risk of death according to positive makers

时间窗: Two years

次要结局

  • Risk of clinical progression according to positive markers.(Two years)
  • Risk of biological progression according to positive markers.(Two years)
  • Risk of radiological progression according to positive markers.(Two years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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