Clinical trial · Interventional
Omitting vs. Doing Intraoperative Frozen Section Biopsy for Margin Status in Breast Conserving Surgery
A Randomized Controlled Trial for Doing vs. Omitting Intraoperative Frozen Section Biopsy For Resection MArgin Status in Selected Patients Undergoing Breast Conserving Surgery
- 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)
* 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
Conditions (1)
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Frozen section biopsy for margin status | Procedure | — | UNRESOLVED |
| Omission of intraoperative frozen section biopsy for margin status | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Frozen section omission
- description
- Intraoperative frozen section biopsy of resection margin will not be performed
- interventionNames
- Procedure: Omission of intraoperative frozen section biopsy for margin status
- type
- ACTIVE_COMPARATOR
- label
- Frozen section
- description
- Intraoperative frozen section biopsy of resection margin will be performed. Margin evaluation of superior, medial, lateral, inferior margin is recommended but will follow surgeon's discretion.
- interventionNames
- Procedure: Frozen section biopsy for margin status
Primary outcomes (1)
- measure
- Resection margin status
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed breast cancer by core needle biopsy with clinical stage T1-3 by American Joint Committee on Cancer(AJCC) 8th edition * Candidate of breast-conserving surgery * Daughter nodule within ≤ 1cm distance of main mass on breast MRI * Non-mass enhancement extent within ≤ 1cm distance of main mass on breast MRI * Ability to understand and willing to sign a written informed consent document : Patients who consent about deciding whether frozen biopsy will be performed by randomization Exclusion Criteria: * cT4 tumors (AJCC 8th edition) * Cancer diagnosis confirmed by vacuum-assisted biopsy or surgical biopsy * Initial operation plan being total mastectomy (conversion to total mastectomy after intraoperative frozen section biopsy is acceptable) * Personal history of ipsilateral breast cancer * Ductal carcinoma in situ component on CNB result * Lobular carcinoma (invasive, in situ) * Neoadjuvant chemotherapy * Lesion with microcalcification (microcalcification that is only contained inside the cancer mass is acceptable) * Multicentric tumor, however a daughter nodule within ≤ 1cm distance on breast MRI is acceptable * Non-mass enhancement extent wider than 1cm distance of main mass on breast MRI
References
Publications (1)
- DERIVEDYoo TK, Kang YJ, Jeong J, Song JY, Kang SH, Lee HY, Kim ET, Yi O, Lee HB, Choi S, Park HS, Gwak G, Kim JI, Kim MK, Lee J, Kang HJ, Chae BJ. A Randomized Controlled Trial for Doing vs. Omitting Intraoperative Frozen Section Biopsy for Resection Margin Status in Selected Patients Undergoing Breast-Conserving Surgery (OFF-MAP Trial). J Breast Cancer. 2021 Dec;24(6):569-577. doi: 10.4048/jbc.2021.24.e51. PMID 34979601