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Omitting vs. Doing Intraoperative Frozen Section Biopsy for Margin Status in Breast Conserving Surgery

NCT03975179 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1292

Last updated 2021-10-21

No results posted yet for this study

Summary

* 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

Interventions

PROCEDURE

Omission of intraoperative frozen section biopsy for margin status

Omitting intraoperative frozen section biopsy for margin status in patients undergoing breast conserving surgery

PROCEDURE

Frozen section biopsy for margin status

Performing intraoperative frozen section biopsy for margin status in patients undergoing breast conserving surgery

Sponsors & Collaborators

  • Korean Breast Cancer Study Group

    collaborator OTHER

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Byung Joo Chae · Samsung Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-24
Primary Completion
2023-06-30
Completion
2026-06-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03975179 on ClinicalTrials.gov