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临床试验/NCT02313623
NCT02313623已完成不适用

MR-US Image Fusion Targeted Biopsy for Single-cell Prostate Cancer Research

Yale University1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2013年7月1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
600
试验地点
1
主要终点
Success Rate of Primary Prostate Cell Culture

研究概览

简要总结

The investigators hypothesize that this single-cell analysis can be used to evaluate prostate needle-core biopsies prospectively even in non-homogenous samples by providing profiles of proteomic and phenotypic signatures. These profiles will in turn enable better predictions of the malignant progression of prostate cancers in the settings of current clinical practice.

详细描述

Current approaches for early detection and diagnosis include prostate-specific antigen (PSA) which is a useful, though not specific, biomarker for detecting prostate cancer. The suspected patients will be further sent for digital rectal examination(DRE), in which a doctor inserts a lubricated, gloved finger into the patient's rectum to feel for lumps, enlargements, or areas of hardness that might indicate prostate cancer. However, the only test that can fully confirm the diagnosis of prostate cancer is a biopsy - the removal of small pieces of the prostate for microscopic examination. If cancer is suspected using PSA test and DRE, more than 90% suspected patients choose undergo prostate biopsy. Prostate needle biopsies are routinely done on an outpatient basis and rarely require hospitalization. Markedly, the fine needle biopsy is minimally invasive and has currently been suggested for longitudinal monitoring of highly suspected patients or follow-up therapeutic responses. The large availability of biopsy samples for prostate cancer provides a cornerstone for the proposed patient specimen-based research. The investigators anticipate that comprehensive analysis rather than simple pathological examination of these samples will generate new insights to prostate tumor progression in human.

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 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Only subjects that have scheduled Artemis prostate biopsy with defined regions of interest will be included in this study

排除标准

  • Any subjects that are unable to provide informed consent will be excluded

研究组 & 干预措施

Patient Scheduled for Prostate Fusion Biopsies

For subjects with scheduled fusion biopsies, we propose a research plan to acquire additional biopsy cores for research purposes without impacting clinical protocol. After acquiring clinically-necessary biopsies, we propose taking an additional research biopsy to establish a matched-pair of clinical and research samples.

干预措施: Prostate Fusion Biopsy (Procedure)

结局指标

主要结局

Success Rate of Primary Prostate Cell Culture

时间窗: 2 years

how often are primary prostate cancer cells able to be grown in culture

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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