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

NCT06505577 | Recruiting

• 1 other identifier: PREPARE-01
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Mastectomy; Breast Neoplasm Malignant Primary

Keywords

Breast cancer; Mastectomy; Ductal carcinoma in situ

Outcome Measures

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.

  Within 30 days after surgery

Secondary Outcomes (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)

  Within 30 days after surgery

• Concordance rate and discrepancy factor in ductal carcinoma in situ (DCIS) subgroup

  Within 30 days after surgery

• Concordance rate and discrepancy factor in neoadjuvant systemic therapy subgroup

  Within 30 days after surgery

• Proportion of surgical method change: rates of unnecessary total mastectomy

  Within 30 days after surgery

• Factors requiring MRI: factors associated with size discrepancy between MRI and mammography (with/without Breast ultrasonography)

  Within 30 days after surgery

Study Arms (1)

Breast cancer surgery group

This cohort includes all patients undergoing breast cancer surgery who are enrolled in the study.

Other: No additional intervention

Interventions

No additional intervention OTHER

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.

Breast cancer surgery group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Incheon St.Mary's Hospital: lead
• Yonsei University: collaborator

Study Sites (1)

Incheon St. Mary's Hospital

Incheon, South Korea

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Central Study Contacts

Young-Joon Kang, Ph.D.

CONTACT

82 32-280-5179; yjkang.md@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 17, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2027
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

KR (1)