Preoperative vs. Pathologic Size in Breast Cancer: A Prospective Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorIncheon St.Mary's Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
The study population will be enrolled from patients at Incheon Saint Mary's Hospital, a 1000-bed tertiary academic medical center located in Incheon, South Korea.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No additional intervention
Other interventionAll patients are scheduled to undergo standard breast surgery as part of their routine clinical care. No additional interventions are administered specifically for this study.
Treatment groups
600 Participants
are divided into 1 treatment groupGroup A: Breast cancer surgery group1 intervention
Trial outcomes
Primary outcomes
1
Concordance rate by the intraclass correlation coefficient Factors associated with discrepancies
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.
Time frame
Within 30 days after surgerySecondary outcomes
1
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)
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. A difference of 5mm or more between preoperative and pathologic measurements is defined as discordance.
Time frame
Within 30 days after surgery2
Concordance rate and discrepancy factor in ductal carcinoma in situ (DCIS) subgroup
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 surgery3
Concordance rate and discrepancy factor in neoadjuvant systemic therapy subgroup
To assess the concordance between preoperative tumor size assessments and pathologic measurements in the subgroup of patients who received neoadjuvant systemic therapy
Time frame
Within 30 days after surgery4
Proportion of surgical method change: rates of unnecessary total mastectomy
To determine the rate of change in surgical method (e.g., from lumpectomy to mastectomy, nipple-sparing to skin-sparing, or vice versa) based on discrepancies between preoperative tumor size assessments and pathologic measurements. This involves collecting the initial surgical method plan from the surgeon before the surgery and, after confirming the pathological size post-surgery, collecting the final surgical method deemed feasible for the patient from the surgeon.
Time frame
Within 30 days after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Incheon St.Mary's Hospital
Lead sponsor
Yonsei University
Collaborator
Source ClinicalTrials.gov