Frozen Section Examination of Sentinel Lymph Nodes in Breast Cancer

May 11, 2026 updated by: Izmir City Hospital

Frozen Section Examination of Sentinel Lymph Nodes in Breast Cancer: A Prospective Randomized Clinical Study

This prospective randomized clinical study evaluates the role of intraoperative frozen section examination of sentinel lymph nodes in patients with breast cancer. The study aims to determine whether frozen section assessment during surgery improves intraoperative decision-making and affects surgical management when compared with standard final pathological evaluation performed after surgery.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • İzmir
      • Izmir, İzmir, Turkey (Türkiye), 35100
        • SBÜ İzmir Şehir Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed with breast carcinoma
  • No prior neoadjuvant treatment

Exclusion Criteria:

  • Inability to localize the sentinel lymph node preoperatively by lymphoscintigraphy or blue dye
  • Previous axillary surgery
  • Recurrent breast cancer
  • Patients who cannot receive radiotherapy
  • Prior neoadjuvant treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Frozen Section Group
Participants undergo sentinel lymph node biopsy with intraoperative frozen section examination. Sentinel lymph nodes are identified using blue dye and a gamma probe, and intraoperative decision-making regarding additional axillary intervention is based on frozen section results.
Diagnostic test: Intraoperative Frozen Section Examination of Sentinel Lymph Node
Sentinel lymph nodes are rapidly transported to pathology without formaldehyde fixation and are evaluated intraoperatively by frozen section.
Active Comparator: Routine Histopathology Group
Participants undergo sentinel lymph node biopsy without intraoperative frozen section. Sentinel lymph nodes are identified using blue dye and a gamma probe, then processed after formaldehyde fixation with routine histopathological evaluation. Further axillary treatment is decided according to final pathology and tumor board assessment.
Diagnostic test: Routine Postoperative Histopathological Evaluation of Sentinel Lymph Node
Sentinel lymph nodes are processed after formaldehyde fixation and evaluated with routine histopathology after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants randomized to the frozen section group and the routine histopathology group
Time Frame: From first participant enrollment until the target sample size is reached, up to 1 year
Count of participants randomized by sealed-envelope method to either intraoperative frozen section evaluation of sentinel lymph nodes or routine histopathological evaluation after formalin fixation. This outcome will be reported as the total number of randomized participants until the protocol-defined target sample size for between-group comparison is reached (planned total sample size: 142 participants).
From first participant enrollment until the target sample size is reached, up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants in the routine histopathology group who require axillary lymph node dissection
Time Frame: From surgery until final histopathological evaluation and multidisciplinary treatment decision, up to 30 days
Percentage of participants assigned to the routine histopathology group without intraoperative frozen section who require axillary lymph node dissection based on final histopathological evaluation and multidisciplinary treatment decision.
From surgery until final histopathological evaluation and multidisciplinary treatment decision, up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir City Hospital

Investigators

  • Principal Investigator: Orhan Ureyen, Prof. / MD, Izmir City Hospital / General Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

May 3, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Breast

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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