Preoperative vs. Pathologic Size in Breast Cancer: A Prospective Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No additional intervention.
- Who it may be relevant to
- Registry conditions: Mastectomy, Breast Neoplasm Malignant Primary. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Concordance Between Preoperative Assessments and Pathologic Size Measurements in Breast Cancer: a Prospective Observational Study
Overview
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.
Interventions
- Other No additional intervention
All patients are scheduled to undergo standard breast surgery as part of their routine clinical care. No additional interventions are administered specifically for this study.
Primary outcome measures
- Concordance rate by the intraclass correlation coefficient Factors associated with discrepancies [Time frame: Within 30 days after surgery]
Secondary outcome measures (6)
- 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) [Time frame: Within 30 days after surgery]
- Concordance rate and discrepancy factor in ductal carcinoma in situ (DCIS) subgroup [Time frame: Within 30 days after surgery]
- Concordance rate and discrepancy factor in neoadjuvant systemic therapy subgroup [Time frame: Within 30 days after surgery]
- Proportion of surgical method change: rates of unnecessary total mastectomy [Time frame: Within 30 days after surgery]
- Factors requiring MRI: factors associated with size discrepancy between MRI and mammography (with/without Breast ultrasonography) [Time frame: Within 30 days after surgery]
- Rate of recurrence within 1-year after breast surgery [Time frame: Within 1 year after enroll]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Incheon St. Mary's Hospital — Incheon
Identifiers
NCT: NCT06505577 · PREPARE-01