Development of a Diagnostic Prediction Model for de Novo Metastatic Breast Cancer Using Routinely Available Baseline Parameters
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 925
- 试验地点
- 1
- 主要终点
- De novo metastatic breast cancer
研究概览
简要总结
The goal of this observational study is to create a tool to estimate the risk of macroscopic distant tumor spread in women with newly diagnosed breast cancer. The main question it aims to answer is:
• Can a model, which combines routine medical information collected at diagnosis, accurately predict if a patient has metastasis large enough to be found during systemic imaging? Researchers will review the past medical records of participants who were treated at a university hospital. Because this study looks at past data, participants will not be asked to do any new tasks, take new tests, or change their medical care.
详细描述
BACKGROUND AND RATIONALE
Baseline risk assessment traditionally relies on anatomical extent, while intrinsic tumour aggressiveness is established as a key determinant of distant spread. In addition, the systemic inflammatory response is increasingly recognized as a driver of tumour progression. The evaluation of these diverse and often conflicting factors complicates early clinical decision-making.
OBJECTIVE
The objective of this study is to develop and internally validate a multivariable diagnostic prediction model using routinely available baseline parameters to estimate the individualised probability of macroscopic distant metastasis among patients with newly diagnosed invasive breast cancer.
STUDY DESIGN AND SETTING
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex, aged 18 years or older.
- •Newly diagnosed invasive breast cancer.
- •Case reviewed by the Multidisciplinary Tumour Board at the study site during the inclusion period (between October 1, 2018, and July 31, 2025).
- •No history of prior or synchronous invasive malignancies, except for synchronous bilateral breast cancer.
- •Intent for primary treatment and clinical management at the study site.
- •Availability of longitudinal clinical records throughout the 12-month follow-up period or until death.
排除标准
- •Absence of baseline systemic staging.
研究组 & 干预措施
Primary study cohort
结局指标
主要结局
De novo metastatic breast cancer
时间窗: From the initial diagnostic mammogram up to 12 months of follow-up.
A newly diagnosed breast cancer with distant spread identified at baseline systemic staging. Distant lesions are categorized as de novo metastasis if confirmed via biopsy, secondary imaging, follow-up imaging, or Multidisciplinary Tumor Board consensus based on definitive clinical evidence. Equivocal cases are adjudicated through a review of the 12 month clinical follow-up.
次要结局
- Incidence of rapid metastatic recurrence(Up to 12 months from the initial diagnostic mammogram.)
- Systemic staging interval(Up to 12 months from the initial diagnostic mammogram.)
- Diagnostic interval(Up to 12 months from the initial diagnostic mammogram.)
研究者
Oliver Laszlo Stari
Principal Investigator
Markusovszky University Teaching Hospital os County Vas