Impact of systematic shaving on tumor margins in breast cancer surgery
Reduction of Affected Margins in Conservative Surgery for Breast Cancer: Impact of Systematic Shaving in the Operating Room
This study tests if a new shaving technique during breast cancer surgery can help reduce the chances of leftover cancer cells and the need for more surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 234 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hospital Universitari de Bellvitge Academic / other |
| Locations | 1 site (L'Hospitalet de Llobregat, Barcelona) |
| Trial ID | NCT05782686 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a systematic shaving technique during breast-conserving surgery to reduce positive margins in patients with breast cancer. Patients are randomized into two groups: one receiving the shaving intervention and the other undergoing standard surgery. The primary goal is to compare the outcomes in terms of definitive pathology and the need for additional interventions due to margin issues. This approach seeks to improve surgical outcomes and minimize the likelihood of further surgeries.
Who should consider this trial
Good fit: Ideal candidates are women undergoing breast-conserving surgery for breast cancer with a confirmed diagnosis of carcinoma in situ or infiltrating.
Not a fit: Patients who may not benefit include men, those with a history of breast cancer, or those requiring mastectomy.
Why it matters
Potential benefit: If successful, this technique could lead to fewer positive margins and reduce the need for additional surgeries in breast cancer patients.
How similar studies have performed: While the specific approach of systematic shaving is novel, similar studies focusing on margin management in breast cancer surgery have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Breast-conserving surgery. 2. Imaging diagnosis as the only breast tumor focus according to mammography, breast ultrasound and/or nuclear magnetic resonance; 3. Pathological diagnosis of carcinoma in situ or infiltrating 4. Oncoplastic without associated flaps; Exclusion Criteria: 1. Male patients; 2. Patients with a history of ipsilateral breast cancer. 3. Oncoplastic that includes flaps 4. Multifocality or multicentricity; 5. Pregnant or lactating patient; 6. Stage IV patients; 7. Patients eligible for mastectomy;
Where this trial is running
L'Hospitalet de Llobregat, Barcelona
- Hospital de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Amparo Garcia Tejedor, MDPhD — Hospital de Bellvitge. Instituto de Investigación Biomédica de Bellvitge (IDIBELL)
- Study coordinator: amparo garcia-tejedor, MDPhD
- Email: agarciat@bellvitgehospital.cat
- Phone: 932607695
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.