Use of Machine Learning Techniques for Serial Assessment of Systemic Inflammatory Markers in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 4,500
- 试验地点
- 13
- 主要终点
- Overall survival
研究概览
简要总结
Breast cancer is the most common cancer in women globally, with 2.3 million new cases diagnosed in 2020. Hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer is the most prevalent subtype, comprising 69% of all breast cancers in the USA. Within the tumor immune microenvironment, a higher intensity of myeloid cell infiltration and low levels of lymphocyte infiltration have been associated with worse outcomes. Markers in peripheral blood have emerged as predictive biomarkers that can be easily obtained non-invasively and at low cost. Experiments have confirmed the relative components of these tests (such as the immune cells) directly or indirectly participated in tumour occurrence, development, and immune escape, underscoring the potential use of laboratory tests as tumour biomarkers
详细描述
In breast cancer, increased neutrophil levels and decreased lymphocyte levels in peripheral blood are associated with worse overall survival (OS). In HR+, HER2- metastatic breast cancers, low pretreatment NLR and high pretreatment absolute lymphocyte count (ALC) were related with better progression-free survival (PFS) and OS. The development of predictive models, based on machine learning (ML) algorithms it has been used in prognostication and assist in the diagnosis of different types of cancer.
Although regular laboratory tests have potential to be breast cancer biomarkers, a single test is yet to provide adequate sensitivity or specificity. Artificial intelligence (AI) could help with integrating data from multiple tests to aid diagnosis. Technical improvements such as data storage capacity, computing power, and better algorithms mean that ML can process clinically meaningful information from laboratory test data. Models' generalisability and stability still need to be confirmed, in view of limitations such as the absence of various pathological types, small cohorts, and lack of external validation. Therefore, a competitive model is also essential to achieve more accurate stratification of patients with breast cancer. The purpose of this retrospective multicentre study is to systematically evaluate the ability of laboratory tests to predict breast cancer, and develop a robust and generalisable model to assist in identifying patients with breast cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women patients with age between 18 and 75 years old;
- •Invasive breast carcinoma patients diagnosed by pathology ;
- •Patients diagnosed between 1 January 2013 and 31 December 2018;
- •Have a complete blood count performed before the surgical intervention (mastectomy or conservative breast surgery) or neoadjuvant chemotherapy;
排除标准
- •Presence of hematological disorders;
- •Bilateral breast cancer;
- •Karnofsky Performance Status Score < 70';
- •Inflammatory breast cancer and in situ carcinoma;
- •Pregnancy or breastfeeding;
- •Evidence of local or distant recurrence.
结局指标
主要结局
Overall survival
时间窗: From the date of diagnosis to the date of death, assessed up to 120 months
Overall survival
次要结局
- Disease free survival(From the date of diagnosis to the date of first progression (local recurrence of tumor or distant metastasis), assessed up to 60 months)
研究者
Afonso Celso Pinto Nazario
Professor and Coordinator at the Department of Gynecology at EPM/UNIFESP.
Federal University of São Paulo
