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Recruiting Observational

Preoperative vs. Pathologic Size in Breast Cancer: A Prospective Study

NCT06505577 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2024-08-01
Last updated
2025-04-06

Condition(s) studied

MastectomyBreast Neoplasm Malignant Primary

Investigational drug(s) / intervention(s)

No additional intervention

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.

Study 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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Concordance rate by the intraclass correlation coefficient Factors associated with discrepancies — 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.

Trial sites (1)

FacilityCityRegionStatus
Incheon St. Mary's Hospital Incheon South Korea Recruiting

More Incheon St.Mary's Hospital trials in South Korea

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06505577 on ClinicalTrials.gov ↗ ← All trials in South Korea