跳至主要内容
临床试验/NCT02156414
NCT02156414已完成不适用

Lymph Node Involvement Using Extended Pelvic Lymphadenectomy in Clinically Localized Prostate Cancer in Bogota Colombia.

Javeriana University3 个研究点 分布在 1 个国家目标入组 135 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
135
试验地点
3
主要终点
Lymph Node Involvement Using Extended Pelvic Lymphadenectomy by histopathology analysis

研究概览

简要总结

Prostate cancer is considered the fourth most common malignancy cancer in America. However, in Colombia the incidence is higher, and it is considered the second cause of death among men for malignance diseases. In the framework of clinical localized prostate cancer there is a controversy regarding the best predictors of risk and the best treatment options. The actual literature is discussing the possibility of underestimate the disease and actual tools are not sufficient for proper characterization. Is in this context that extended pelvic lymphadenectomy emerges as a stratification tool in prostate cancer that defines the real commitment of the disease. The investigators need to know the characteristics that the disease has on the investigators community so the investigators can generate appropriate therapeutic approach. Thus, the present prospective observational-descriptive multicenter study, want to determine in three referral centers in Bogotá Colombia , the frequency of pelvic node involvement in patients with localized clinical prostate cancer from the stratification achieved by pelvic lymphadenectomy extended.

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

入选标准

  • Patients with clinical localized prostate cancer
  • Clinical stage: cT1-cT2-, N0-Nx, M0-Mx
  • Patients who undergo radical prostatectomy and extended lymphadenectomy in one of the 3 centers of reference.

排除标准

  • Patients in which the standard technique of the extended lymphadenectomy could not be done and it was changed.

结局指标

主要结局

Lymph Node Involvement Using Extended Pelvic Lymphadenectomy by histopathology analysis

时间窗: within the first 30 days after surgery

After extended pelvic lymphadenectomy the nodes are classified in ilio-obturator nodes and internal iliaca nodes. Then those nodes are send to the pathology department of the each center, and by the histopathology analysis, the pathologist determine which nodes are compromised. With the histopathology result, the investigators report de nodal involvement.

次要结局

  • The Histopathology substaging Gleason score in the surgery piece vs Biopsy report before surgery.(Within the first 30 days after surgery)

研究者

发起方
Javeriana University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose Gustavo Ramos

MD, Urology Resident

Javeriana University

研究点 (3)

Loading locations...

相似试验