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临床试验/NCT03941639
NCT03941639终止不适用

Using Imaging Data and Genomic Data to Predict Metastasis of Breast Cancer After Treatment

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
95
试验地点
1
主要终点
area under the receiver operating characteristic curve (AUC)

研究概览

简要总结

Breast cancer is the second leading cause of death for women around the world. Notably, most breast cancer patients die from tumor metastases in the liver, lungs, bones, or brain, not the primary tumor itself. Currently, clinicians are generally successful in treating primary tumors using standard protocols that are based on tumor sub-type and staging, as well as by the presence or absence of prognostic biomarkers. However, it remains difficult to assess in advance the likelihood of metastasis or relapse in any given patient.Physicians can only rely on regular post-treatment screening to monitor any secondary onset. By the time metastasis is detected, the golden window for treatment adjustment has often already passed.

This project proposes to develop an analytical tool for predicting the likelihood of metastasis in breast cancer patients post-treatment using imaging and genomic data. We will evaluate our prediction model using prospectively-collected patient data. This new prognostic tool will enable physicians to adjust and tailor therapeutic strategies to each patient in a timely manner. Overall, the tool will personalize patient care, and improve their survival chances and quality of life.

详细描述

Background

Breast cancer is the second leading cause of death in women around the world. According to WHO statistics, 571,000 women passed away in 2015 due to breast cancer alone. In Hong Kong, breast cancer is the most common cancer among women.

Currently, the standard protocol in breast cancer treatment consists of surgery (mastectomy), chemotherapy, radiotherapy, and possibly hormone therapy or targeted therapy depending on the presence or absence in tumor cells of certain hormone receptors such as estrogen receptors (ER), progesterone receptors (PR), or human epidermal receptor 2 (HER2). The standard protocol aims to remove the tumor and kill any remaining tumor cells. The treatment is usually adjusted based on the patients' tolerance and general health status. The standard protocol has so far been very effective in treating patients with early-stage breast cancers. The 5-year relative survival rate can be higher than 90% if patients are treated early enough. But it is still very challenging to treat patients with middle- or late-stage breast cancers, especially those with metastatic disease. For patients with metastases, the 5-year relative survival rate drops to around 20%. There are two major reasons for this drop.

While all breast cancers start from the same organ, the evolution of cancer cells shows different patterns in different patients. This is especially true when breast cancers are advanced into the middle or late stages. The standard protocol, however, is based on averaged patient statistics and does not fully account for the uniqueness of individuals. For example, patients with different genomic backgrounds respond differently to the same drug dosage and experience different side effects. Thus, population-based treatment strategies cannot provide effective, optimal treatment for every patient, especially for patients with middle- or late-stage breast cancer.

The clinical gold standard for cancer diagnosis is multi-modality imaging: mammogram and ultrasound, plus pathology of biopsied tissue. Imaging has been effective in detecting primary breast cancers but it becomes less effective for monitoring patients post-treatment because their primary tumors and affected lymph nodes have been removed. While physicians still rely on image-based screening of organs such as the lungs and liver where metastases have become established to monitor their patients post-treatment, such screening tests are not sensitive enough. Patients with greater risk of metastasis often miss the best window of opportunity for therapy adjustment before the secondary onset. When metastasis is observed in other parts of the body a few years later, often it is already too late for any effective intervention.

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • Clinical diagnosis of breast cancer
  • With mammogram
  • With surgical treatment
  • With chemotherapy, radiotherapy or both

排除标准

  • Clinical diagnosis of other major diseases

结局指标

主要结局

area under the receiver operating characteristic curve (AUC)

时间窗: Four years after patient recruitment

AUC in percentage (%) in breast cancer metastasis prediction model

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

Professor Winnie W.C. Chu

Professor

Chinese University of Hong Kong

研究点 (1)

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