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临床试验/NCT06689605
NCT06689605招募中不适用

Ultrasound-guided Tru-cut Biopsy in Patients with Suspected Ovarian Cancer: Adequacy, Accuracy, Safety and Patient Assessment.

University Hospital Hradec Kralove1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
Adequacy of tru-cut biopsy in ovarian cancer

研究概览

简要总结

The goal of this prospective observational study is to evaluate the role of ultrasound-guided tru-cut biopsy (in the hands of an expert certified sonographer within a gynecological center)in patients with suspected ovarian cancer.

The main questions it aims to answer are:

Is the material from tru-cut biopsy adequate for histopathological and immunohistochemical examination? Is the material accurate in comparison with the final pathological specimen? What are the patient experience and complications after the procedure?

Participants who will undergo a standard tru-cut biopsy procedure will need to additionally answer the questionnaire.

详细描述

  1. Current State of Knowledge

Ovarian cancer remains the most lethal gynecologic malignancy, largely due to the lack of early detection and its presentation at a late stage1,2. In patients with ovarian cancer, the most important prognostic factor is the absence of macroscopic tumor at the end of surgery as well as the histological type3. For this purpose, adequate imaging before surgery, as well as histological knowledge of the tumor before the application of neoadjuvant chemotherapy is of great essence. Ultrasound-guided or CT-guided tru-cut biopsy in patients with advanced ovarian cancer has slowly become the preferred method of histological verification over the last decade in patients with suspected advanced ovarian cancer, with prof. Fischerová and her team being the pioneers in its use4,5.

Our aim is to prospectively evaluate the role of ultrasound-guided tru-cut biopsy in the hands of an expert certified sonographer within a gynecological oncological center and with the material examined by a concrete expert in the gynecological oncological pathology field. The novelty in our approach so to say will lie in these three factors: prospective design, two expert sonographers, and one expert pathologist. This project will also be the first to include a patient experience survey after the procedure. Furthermore, with this project, we will be able to create a prospective database allowing for further work in the future. 2. Material Support for the Project

The ultrasound examination will be performed on the GE Voluson E10 system located in the gynecological oncology center, tru-cut biopsy will be performed using a fast-gun automated biopsy system for sampling with 16-18 Gauge tru-cut needle and a G/16-30 cm core-cut biopsy needle. Histological examination will be performed in the state of art Fingerland department of pathology. 3. Project Objectives

The goal of this project is to assess the adequacy of the material obtained from ultrasound-guided tru-cut biopsy for histopathological and immunohistochemical examination, compare for the accuracy of the histopathological diagnosis in samples with adequate material using the definitive surgical specimen as the reference standard while prospectively registering patient experience and complications after the procedure. 4. Methodology

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • suspected advanced ovarian cancer
  • indication for tru-cut biopsy by multidisciplinary oncoboard

排除标准

  • patient deny to undergo tru-cut biopsy

结局指标

主要结局

Adequacy of tru-cut biopsy in ovarian cancer

时间窗: From the tru-cut biopsy to the histopathological result.

Evaluation of the adequacy of the procedure in diagnosing ovarian cancer by histopathological and immunohistochemical examination.

次要结局

  • Accuracy of tru-cut biopsy in ovarian cancer(From the tru-cut biopsy to the definitive histopathological examination from the surgery.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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