Early Stage Breast CancerNCT07244588
Shaving as an Safe Alternative to Frozen Section Analysis
A study testing Tumor bed cavity shaving in people with Early Stage Breast Cancer, run by Mark Ezzat Gerges at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Stage Breast Cancer
- What is being tested?
- Tumor bed cavity shaving
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged ≥18 years.
- Diagnosed with unifocal, operable invasive breast carcinoma.
- Suitable for breast-conserving surgery. Criteria:
Who cannot join
- -Contraindication of Breast-Conserving Surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Faculty of Medicine Assiut University
Asyut, 71515
Faculty of medicine Assiut University, 088 2411900, med@aun.edu.eg
About this study
Official title: Evaluation of Tumor Bed Cavity Shaving as an Oncologically Safe Alternative to Frozen Section Analysis in Breast-Conserving Surgery
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.
Read the detailed description
Breast cancer remains the most common malignancy among women worldwide and represents a major health burden. Breast-conserving surgery (BCS) has become the standard of care for early-stage breast cancer, aiming to achieve complete tumor excision with histologically clear margins combined with adjuvant radiotherapy, offers equivalent survival rates to mastectomy in early-stage cases.
. Positive surgical margins are strongly associated with increased rates of local recurrence and frequently necessitate re-excision.
Traditionally, intraoperative frozen section analysis (FSA) has been used to assess margin status. However, this technique has several drawbacks, including:
- Limited availability in many centers.
- Requires high-experienced cytopathologists making it challenging in resource-limited places.
- Adds substantial cost.
- Time consuming (prolonged operative time).
- Recently, the tumor bed cavity shaving (TBCS) has been introduced as a more practical alternative technique that can reduce the incidence of positive margins without relying on intraoperative pathology. tumor bed cavity shaving (TBCS) means additional thin layers of tissue approximately 5:10 mm in thickness are removed circumferentially from the cavity walls .
With many advantages:
- 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.
- Conditions
- Early Stage Breast Cancer
- Being tested
- Tumor bed cavity shaving
- Keywords
- Breast cancer, Breast conserve surgery, low socioeconomic settings, Shaving, Margin status, Fresh frozen section, Operative time, Safe Alternative
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor bed cavity shavingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Tumor bed cavity shaving |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From time of enrollment of the patient until 2 years post-operative
Secondary outcomes (1)
- Cost-effectiveness - Facilities availability - Impact on intraoperative time
- Cost-effectiveness Description: Total direct cost incurred per patient from surgery through 2 years of follow-up, including operative costs, pathology, imaging, and any re-operations. Unit of Measure: Currency Measurement Tool: cost-analysis using hospital accounting data.
- Facilities availability Description: Frequency of use and availability of required surgical infrastructure during the study period. Unit of Measure: Number / proportion (for example, number of surgeries per facility per month, or percentage of scheduled surgeries using the study's protocol) Measurement Tool: Hospital operation records, facility logbooks or administrative databases.
- Impact on intraoperative time Description: Difference in surgical duration (minutes) between standard procedure and the procedure under study, if applicable.
Unit of Measure: Minutes Measurement Tool: Operative records / anesthesia records. Time Frame: from incision to closure.
Measured: From enrollment time of the patient until 2 years post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study startDec 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mark Ezzat Gerges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mark Ezzat Gerges, Assiut University
- Investigators
- Mostafa Thabet, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07244588
- Sponsor's protocol ID
- TBCS as an alternative to FFS
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tumor Bed Cavity Shaving as an Oncologically Safe Alternative to Frozen Section Analysis in Breast-Conserving Surgery
- ClinicalTrials.gov ID
- NCT07244588
- Acronym / sponsor ID
- TBCS as an alternative to FFS
- Conditions
- Early Stage Breast Cancer
- Keywords
- Breast cancer, Breast conserve surgery, low socioeconomic settings, Shaving, Margin status, Fresh frozen section, Operative time, Safe Alternative
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mark Ezzat GergesUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Breast cancer remains the most common malignancy among women worldwide and represents a major health burden. Breast-conserving surgery (BCS) has become the standard of care for early-stage breast cancer, aiming to achieve complete tumor excision with histologically clear margins combined with adjuvant radiotherapy, offers equivalent survival rates to mastectomy in early-stage cases.
. Positive surgical margins are strongly associated with increased rates of local recurrence and frequently necessitate re-excision.
Traditionally, intraoperative frozen section analysis (FSA) has been used to assess margin status. However, this technique has several drawbacks, including:
- Limited availability in many centers.
- Requires high-experienced cytopathologists making it challenging in resource-limited places.
- Adds substantial cost.
- Time consuming (prolonged operative time).
- Recently, the tumor bed cavity shaving (TBCS) has been introduced as a more practical alternative technique that can reduce the incidence of positive margins without relying on intraoperative pathology. tumor bed cavity shaving (TBCS) means additional thin layers of tissue approximately 5:10 mm in thickness are removed circumferentially from the cavity walls .
With many advantages:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tumor bed cavity shaving arm | Experimental | Procedure: Tumor bed cavity shavingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients aged ≥18 years.
- Diagnosed with unifocal, operable invasive breast carcinoma.
- Suitable for breast-conserving surgery. Criteria:
Key exclusion criteria (1 listed)
- -Contraindication of Breast-Conserving Surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor bed cavity shavingfeasible 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. | Procedure or surgery | Tumor bed cavity shaving arm |
Primary outcome
Rate of positive margins and re-excision within 2 years post-surgery
Time frame: From time of enrollment of the patient until 2 years post-operative
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.
1 secondary outcome
- Cost-effectiveness - Facilities availability - Impact on intraoperative time
Time frame: From enrollment time of the patient until 2 years post operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mostafa Thabet study chair
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tumor bed cavity shaving in people with Early Stage Breast Cancer, run by Mark Ezzat Gerges at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Ezzat Gerges, Resident doctor (+201229385677, markezzat99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of positive margins and re-excision within 2 years post-surgery (time frame: From time of enrollment of the patient until 2 years post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.