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临床试验/NCT03563781
NCT03563781已完成不适用

SEntine Lymph Node in earLY Ovarian Cancer

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2017年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
176
试验地点
1
主要终点
Detection rate

研究概览

简要总结

The present study aims at investigating the feasibility, the detection rate and the negative predictive value of sentinel node in predicting the presence or absence of lymph node metastasis in ovarian cancer patients

详细描述

Patients with early stage ovarian cancer have a good prognosis. However, nearly 15% of the initially diagnosed as early stage ovarian cancers, will be upstaged after an appropriate surgical staging due to lymphatic metastasis, despite of preoperative radiological data. Therefore, complete pelvic and para-aortic lymphadenectomy in these patients represents a crucial procedure. On the other hand, nodal dissection may be associated with threatening intra- and post-operative complications.

If feasible and accurate, the sentinel lymph node procedure could be a modality to avoid unnecessary radical lymphadenectomy without missing important information on nodal status.

With the present study we aim at exploring the role of sentinel node dissection in early ovarian cancer patients.

Patients with ovarian cancer macroscopically limited to the ovary (early ovarian cancer) will receive injection of a tracer (patent blue or indocyanine green) which have already been proven safe and extremely effective in several other gynecologic and non-gynecologic malignancies. Then the retroperitoneal spaces will be opened as for a standard lymphadenectomy procedure and the lymph node marked with the tracer will be identified. After dissection of the sentinel node, lymphadenectomy will be completed according to current guidelines.

Operative data, pathological findings and accuracy of sentinel node in predicting nodal status will be registered.

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

入选标准

  • Epithelial ovarian cancer
  • Early stage disease limited to the ovary

排除标准

  • Evidence of extraovarian disease
  • Allergy to the materials used

结局指标

主要结局

Detection rate

时间窗: 24 months

The rate of patients in whom the sentinel node is detected

Number of participants with procedure-related adverse events

时间窗: 6 months

The number of patients with procedure-related adverse events as assessed by CTCAE v4.0

次要结局

  • Negative predictive value(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

SCAMBIA GIOVANNI

Professor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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