Clinical trial · Observational
Preoperative vs. Pathologic Size in Breast Cancer: A Prospective Study
Concordance Between Preoperative Assessments and Pathologic Size Measurements in Breast Cancer: a Prospective Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm Malignant Primary | — | UNRESOLVED | — |
| Mastectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No additional intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breast cancer surgery group
- description
- This cohort includes all patients undergoing breast cancer surgery who are enrolled in the study.
- interventionNames
- Other: No additional intervention
Primary outcomes (1)
- measure
- Concordance rate by the intraclass correlation coefficient Factors associated with discrepancies
- timeFrame
- Within 30 days after surgery
- description
- 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 (6)
- measure
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available