Shaving as an Safe Alternative to Frozen Section Analysis

NCT07244588 | Not Yet Recruiting

• 1 other identifier: TBCS as an alternative to FFS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of Tumor Bed Cavity Shaving as an Oncologically Safe Alternative to Frozen Section Analysis in Breast-Conserving Surgery and aim of study To assess the oncological safety and practicality of tumor bed cavity shaving also aims to evaluate its impact on operative time and overall cost.

Conditions

Early Stage Breast Cancer

Keywords

Breast cancer; Breast conserve surgery; low socioeconomic settings; Shaving; Margin status; Fresh frozen section; Operative time; Safe Alternative

Outcome Measures

Primary Outcomes (1)

• Rate of positive margins and re-excision within 2 years post-surgery

  Percentage of patients whose surgical pathology shows positive margins, and percentage of patients who undergo re-excision. Assessment will be based on histopathology reports and surgical records. Unit of Measure: percentage number of patients Measurement Tool: Histopathological examination (pathology report) for margin status; surgical database/operative logs for re-excision events.

  From time of enrollment of the patient until 2 years post-operative

Secondary Outcomes (1)

• - Cost-effectiveness - Facilities availability - Impact on intraoperative time

  From enrollment time of the patient until 2 years post operative

Study Arms (1)

Tumor bed cavity shaving arm

EXPERIMENTAL

Patients undergoing breast-conserving surgery will receive intraoperative tumor bed cavity shaving as an alternative approach to ensure clear surgical margins. Additional cavity shavings will be taken circumferentially after the primary lumpectomy specimen. The outcomes will be compared with standard margin assessment methods.

Procedure: Tumor bed cavity shaving

Interventions

Tumor bed cavity shaving PROCEDURE

feasible in centers lacking intraoperative pathological facilities. * Time saving (significantly reduces the overall operative time). * cost-effectiveness. * Technically simple (Easy to perform without the need for specialized equipment or advanced facilities). * it represents a suitable option in low- to medium-socioeconomic settings, where resources and advanced intraoperative support may be limited. * It is expected to demonstrate comparable oncological safety to Intraoperative Frozen Section Analysis (FSA) in achieving margin negativity with Significant reduction anticipated in Positive margin rates\&Re-excision frequency\&Operative duration and Overall procedural cost.

Tumor bed cavity shaving arm

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged ≥18 years.
• Diagnosed with unifocal, operable invasive breast carcinoma.
• Suitable for breast-conserving surgery. Criteria:

You may not qualify if:

• Contraindication of Breast-Conserving Surgery.

Sponsors & Collaborators

• Mark Ezzat Gerges: lead

Study Sites (1)

Faculty of Medicine Assiut University

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Mostafa Thabet

  Assiut University

  STUDY CHAIR

Central Study Contacts

Mark Ezzat Gerges, Resident doctor

CONTACT

+201229385677; markezzat99@gmail.com

Nagm elden Abu elnaga, Ph D

CONTACT

+201015417979; nagmdairy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Physician at General surgery department Assiut University Hospital

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 24, 2025
• Study Start: December 1, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

EG (1)