Clinical trial · Interventional
Shaving as an Safe Alternative to Frozen Section Analysis
Evaluation of Tumor Bed Cavity Shaving as an Oncologically Safe Alternative to Frozen Section Analysis in Breast-Conserving Surgery
NCT07244588CI-TRIAL-00097792not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tumor bed cavity shaving | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tumor bed cavity shaving arm
- description
- 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.
- interventionNames
- Procedure: Tumor bed cavity shaving
Primary outcomes (1)
- measure
- Rate of positive margins and re-excision within 2 years post-surgery
- timeFrame
- From time of enrollment of the patient until 2 years post-operative
- description
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female patients aged ≥18 years. * Diagnosed with unifocal, operable invasive breast carcinoma. * Suitable for breast-conserving surgery. Criteria: Exclusion criteria: -Contraindication of Breast-Conserving Surgery.
References
Publications (0)
Data not yet available
No reference posted for this study.