Concordance Between Preoperative Assessments and Pathologic Size Measurements in Breast Cancer: a Prospective Observational Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mastectomy
- Sponsor
- Incheon St.Mary's Hospital
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Concordance rate by the intraclass correlation coefficient Factors associated with discrepancies
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Young-Joon Kang
Assistant Professor
Incheon St.Mary's Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Concordance rate by the intraclass correlation coefficient Factors associated with discrepancies
Time Frame: 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.
Secondary Outcomes
- 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)