Clinical trial NCT06505577: Preoperative vs. Pathologic Size in Breast Cancer: A Prospective Study
Official title: Concordance Between Preoperative Assessments and Pathologic Size Measurements in Breast Cancer: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mastectomy
Breast Neoplasm Malignant Primary
Keywords: Breast cancer
Mastectomy
Ductal carcinoma in situ
Lead sponsor: Incheon St.Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Yonsei University
First posted: 2024-07-17
Enrollment: 600
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

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.

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

Primary outcomes:
measure: Concordance rate by the intraclass correlation coefficient Factors associated with discrepancies
timeFrame: Within 30 days after surgery
Secondary outcomes:
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)
timeFrame: Within 30 days after surgery
measure: Concordance rate and discrepancy factor in ductal carcinoma in situ (DCIS) subgroup
timeFrame: Within 30 days after surgery
measure: Concordance rate and discrepancy factor in neoadjuvant systemic therapy subgroup
timeFrame: Within 30 days after surgery
measure: Proportion of surgical method change: rates of unnecessary total mastectomy
timeFrame: Within 30 days after surgery
measure: Factors requiring MRI: factors associated with size discrepancy between MRI and mammography (with/without Breast ultrasonography)
timeFrame: Within 30 days after surgery
measure: Rate of recurrence within 1-year after breast surgery
timeFrame: Within 1 year after enroll
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Incheon St. Mary's Hospital
Study officials:
References: