Actively Recruiting
Omitting vs. Doing Intraoperative Frozen Section Biopsy for Margin Status in Breast Conserving Surgery
Led by Samsung Medical Center · Updated on 2021-10-21
1292
Participants Needed
2
Research Sites
296 weeks
Total Duration
On this page
Sponsors
S
Samsung Medical Center
Lead Sponsor
K
Korean Breast Cancer Study Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
* Study phase: 3 * Indication: Breast cancer patients undergoing breast conserving surgery * Primary objectives: To determine the effect of selective omission of intraoperative margin evaluation via frozen section on margin positive rate Secondary objectives: To determine the effect of selective omission of intraoperative margin evaluation via frozen section on reoperation rate, local recurrence rate, operation time, resection volume, medical cost and patient quality-of life * Hypothesis: Omitting intraoperative margin evaluation via frozen section biopsy in selected breast cancer patients does not increase margin positive rate * Study design: Randomized controlled trial * Sample size: 1292 patients * Procedures: breast conserving surgery +/- margin frozen section biopsy (+/- additional resection)
CONDITIONS
Official Title
Omitting vs. Doing Intraoperative Frozen Section Biopsy for Margin Status in Breast Conserving Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed breast cancer by core needle biopsy with clinical stage T1-3 by AJCC 8th edition
- Candidate for breast-conserving surgery
- Daughter nodule within 64 1 cm distance of main mass on breast MRI
- Non-mass enhancement extent within 64 1 cm distance of main mass on breast MRI
- Ability to understand and willing to sign informed consent for randomization about frozen biopsy
You will not qualify if you...
- cT4 tumors by AJCC 8th edition
- Cancer diagnosis confirmed by vacuum-assisted biopsy or surgical biopsy
- Initial operation plan is total mastectomy (conversion after frozen section biopsy is acceptable)
- Personal history of ipsilateral breast cancer
- Ductal carcinoma in situ component on core needle biopsy
- Lobular carcinoma (invasive or in situ)
- Neoadjuvant chemotherapy
- Lesion with microcalcification outside the cancer mass
- Multicentric tumor except daughter nodule within 64 1 cm on breast MRI
- Non-mass enhancement extent wider than 1 cm from main mass on breast MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Ilsan Paik Hospital
Goyang-si, South Korea
Actively Recruiting
2
Seoul St. Mary's Hospital
Seoul, South Korea
Actively Recruiting
Research Team
B
Byung Joo Chae
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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