跳至主要内容
临床试验/NCT06578988
NCT06578988进行中(未招募)不适用

Use of Artificial Intelligence in the Symptomatic BReAst Clinic SEtting - A Retrospective Study (AI-BRACE)

Royal Marsden NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 25,000 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
25,000
试验地点
1
主要终点
Performance of screening tool on symptomatic data, in terms of sensitivity and specificity.

研究概览

简要总结

Artificial Intelligence (AI) systems for the classification of mammography images have been developed and are beginning to be trialled and deployed in a breast cancer screening setting with encouraging results.

It is reasonable to think that these systems could be useful in the context of symptomatic breast clinic. However, these systems developed in the screening setting have unknown performance in the context of symptomatic breast clinic.

It is therefore important to test the performance of these systems in this alternative context.

This study will use retrospective data, from where it is possible to determine ground truth outcomes with greater confidence, accessing relatively large volumes of data with less patient burden when compared to prospective studies. This important cohort of patients has been less investigated to date, mainly because symptomatic data is typically more difficult to curate than screening data where key data is methodically prospectively collected.

The proposed work will be carried out in collaboration with a selected AI vendor and local clinical teams to define optimal use case scenarios for the symptomatic breast clinic.

详细描述

Patients with breast symptoms are referred from primary care to symptomatic breast clinics, often under the two-week-wait cancer pathway. Clinicians assess the patient's breast symptoms by looking at the patient's personal and family history of cancer, conducting a physical examination, and referring the patient for imaging as required.

Ultrasound and / or mammography are typically performed and reported by the imaging team at the same visit, with biopsy performed when indicated. This service is an important part of cancer care provision, with approximately half of the breast cancers diagnosed presenting via the symptomatic service rather than identified at screening.

It is important to note that cancers diagnosed symptomatically tend to be larger and more aggressive with worse outcome than those diagnosed via screening. The volume of referrals to the National Health Service (NHS) symptomatic service has risen over the last decade, placing increased pressure on service delivery, in breast imaging.

Artificial Intelligence (AI) systems for the classification of mammography images have been developed and are beginning to be trialled and deployed in a breast cancer screening setting with encouraging results. It is reasonable to think that these systems could be useful in the context of symptomatic breast clinic. However, these systems developed in the screening setting have unknown performance in the context of symptomatic breast clinic. It is therefore important to test the performance of these systems in this alternative context.

研究设计

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

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Performance of screening tool on symptomatic data, in terms of sensitivity and specificity.

时间窗: 18 months

次要结局

  • Subgroup analysis based on ground-truth - Normal; Benign; Malignant.(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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