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NCT Number: NCT07591506

Frozen Section Examination of Sentinel Lymph Nodes in Breast Cancer

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SBÜ İzmir Şehir Hastanesi

Izmir, İzmir, 35100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraoperative Frozen Section Examination of Sentinel Lymph Node

Diagnostic Test

Sentinel lymph nodes are rapidly transported to pathology without formaldehyde fixation and are evaluated intraoperatively by frozen section.

Routine Postoperative Histopathological Evaluation of Sentinel Lymph Node

Diagnostic Test

Sentinel lymph nodes are processed after formaldehyde fixation and evaluated with routine histopathology after surgery.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Izmir City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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