跳至主要内容
临床试验/NCT06505577
NCT06505577招募中不适用

Concordance Between Preoperative Assessments and Pathologic Size Measurements in Breast Cancer: a Prospective Observational Study

Incheon St.Mary's Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
600
试验地点
1
主要终点
Concordance rate by the intraclass correlation coefficient Factors associated with discrepancies

研究概览

简要总结

Breast cancer, the most prevalent malignancy among women globally, is increasing in incidence. While non-metastatic breast cancer requires surgery, determining the optimal extent of resection remains challenging. Inadequate resection margins necessitate reoperation, leading to increased psychological stress, costs, and potentially compromised cosmetic outcomes and prognosis.

Accurate preoperative assessment of resection extent is crucial and involves various factors, including imaging studies, physical examinations, tumor molecular subtypes, and intraductal carcinoma components. This prospective observational study aims to identify and integrate multiple predictive factors to enhance surgical planning and minimize reoperation rates in breast cancer patients.

详细描述

Breast cancer is the most prevalent malignancy among women globally, leading to surgical interventions for non-metastatic cases. While breast cancer generally has a favorable prognosis, achieving negative resection margins at initial surgery is crucial for optimal outcomes. The challenge associated with accurately predicting the extent of resection preoperatively, as failure to secure clear margins may necessitate further resection or total mastectomy, resulting in increased psychological stress, higher healthcare costs, compromised cosmetic results, and potential negative impacts on long-term prognosis and quality of life. Many factors contribute to predicting the optimal resection extent, including imaging studies, physical examination findings, tumor molecular subtypes, presence and extent of intraductal carcinoma components, etc. Despite the availability of these predictive factors, their integration and practical application in clinical decision-making remain challenging. This prospective observational study aims to address this gap by analyzing the interplay of these factors in real-world clinical settings, with the primary objective of deriving an integrated predictive model to guide surgeons in determining the optimal extent of resection preoperatively.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (≥ 19 years old) diagnosed with breast cancer (invasive and in situ).
  • Patients scheduled for surgical resection of the tumor Availability of both preoperative tumor size assessments and pathologic measurements post-surgery

排除标准

  • Patients with recurrent breast cancer Inflammatory breast cancer Patients who did not undergo surgery Patients whose preoperative tumor size data is not available or deficient for analyzing

结局指标

主要结局

Concordance rate by the intraclass correlation coefficient Factors associated with discrepancies

时间窗: Within 30 days after surgery

To assess the concordance between preoperative tumor size assessments made by surgeons and the actual tumor size determined by pathologic analysis following surgical resection in patients with breast cancer. * Using the scale of Landis and Koch according to the intraclass correlation coefficient. * With/without MRI status. To identify and evaluate factors associated with discrepancies between preoperative assessments and pathologic measurements.

次要结局

  • Concordance rate by size discordance (5mm) To evaluate the concordance between preoperative tumor size assessments and pathologic measurements in the subgroup of patients with ductal carcinoma in situ (DCIS)(Within 30 days after surgery)
  • Concordance rate and discrepancy factor in neoadjuvant systemic therapy subgroup(Within 30 days after surgery)
  • Rate of recurrence within 1-year after breast surgery(Within 1 year after enroll)
  • Proportion of surgical method change: rates of unnecessary total mastectomy(Within 30 days after surgery)
  • Concordance rate and discrepancy factor in ductal carcinoma in situ (DCIS) subgroup(Within 30 days after surgery)
  • Factors requiring MRI: factors associated with size discrepancy between MRI and mammography (with/without Breast ultrasonography)(Within 30 days after surgery)

研究者

发起方
Incheon St.Mary's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Young-Joon Kang

Assistant Professor

Incheon St.Mary's Hospital

研究点 (1)

Loading locations...

相似试验