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临床试验/NCT03330015
NCT03330015已完成不适用

Patient's Experience and Choice Between Investigations for Endometrial Cancer in Postmenopausal Bleeding

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 206 人开始时间: 2016年6月3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
206
试验地点
1
主要终点
The level of acceptance of false negative rate using TVS ET

研究概览

简要总结

Endometrial cancer is the most common malignancy of the female genital tract in Hong Kong. The aim in the evaluation of PMB is to exclude underlying malignancy. Endometrial thickness (ET) measured by transvaginal ultrasound scanning (TVS) and endometrial biopsy or sampling (ES) has been recommended as the first-line investigation. From a study between 2002-2013 in the One-stop PMB clinic, investigators found that ET was able to identify women with endometrial cancer with the sensitivity at 3mm, 4mm, and 5mm, the current levels recommended in professional guidelines, being 97.0%, 94.1%, and 93.5% respectively. However, little is known about the level of patient's acceptance of the false negative rate and how patient would trade residual risk with more invasive test. There is also a lack of study on the experience of women during the management pathway especially the level of anxiety before and after investigations and the pain experienced from the investigations offered. The current study aim to study the level of false negative rate accepted by women for the investigation of PMB and the level of anxiety and pain experienced during the investigation pathway.

详细描述

Endometrial cancer is the most common malignancy of the female genital tract in Hong Kong. It is estimated that around 10% of women experience postmenopausal bleeding. Around 90% of women with endometrial cancer initially presented with postmenopausal bleeding (PMB). The aim in the evaluation of PMB is to exclude underlying malignancy. Clinical tests to evaluate the endometrium include transvaginal ultrasound scanning (TVS) to measure endometrial thickness (ET), endometrial biopsy or sampling (ES), saline infusion sonography, and hysteroscopy. TVS ET or ES has been recommended as the first-line investigation.

There are, however, different ET cut-off values recommended by various professional groups. From a study between 2002-2013 in the One-stop PMB clinic, investigators found that ET was able to identify women with endometrial cancer with the sensitivity at 3mm, 4mm, and 5mm, the current levels recommended in professional guidelines, being 97.0%, 94.1%, and 93.5% respectively.

Although clinical management guidelines and accuracy data are available, little is known about the level of patient's acceptance of the false negative rate and how patient would trade residual risk with more invasive test. There is also a lack of study on the experience of women during the management pathway especially the level of anxiety before and after investigations and the pain experience from the investigations offered. There is only one study identified from the literature which suggested high levels of anxiety in women who experienced PMB.

There is a dedicated Postmenopausal Bleeding Clinic for the one-stop evaluation for PMB in Hong Kong and investigators receive referrals from other centers in Hong Kong. It is a tertiary-care university institution with two affiliated hospitals.

All patients who are new referrals for the symptom of PMB will be invited to participate in the study. Informed consent form will be obtained from all patients participating in the study. Patients will be asked to read written information on postmenopausal bleeding including the risk of endometrial cancer and investigation options including TVS ET, hysteroscopy and ES. The information will be focused on the detection rate and procedure-related risk. The interviewer will specify that 1) hysteroscopy and ES will be considered to offer 100% detection rate but there is procedure related risks including pain, bleeding, infection, uterine perforation because entrance into the uterine cavity is required 2) TVS ET do not require entry into uterine cavity but the detection rate is not 100%. Then patients will undergo a structured interview by an interviewer using the standard gamble technique.

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
40 Years 至 69 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • postmenopausal woman
  • referrals for the symptom of PMB

排除标准

  • mental retardation

结局指标

主要结局

The level of acceptance of false negative rate using TVS ET

时间窗: Baseline

The level of acceptance of false negative rate using endometrial thickness assessed by transvaginal ultrasound scanning to identify endometrial cancer.

次要结局

未报告次要终点

研究者

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

Fung Wen Ying Linda

Associate Consultant

Chinese University of Hong Kong

研究点 (1)

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