Margin, Tumor-FreeNCT05782686
Impact of Systematic Shaving on Margins
A study testing Margin shaving in people with Margin, Tumor-Free and Breast Cancer, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
The objective of this clinical trial is to demonstrate the reduction of positive margins in the definitive pathology of patients undergoing breast-conserving surgery with the systematic shaving technique compared to conventional surgery, and the reduction of second interventions for margin enlargement. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Margin, Tumor-Free, Breast Cancer, Surgery
- What is being tested?
- Margin shaving
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteSpain
- Study dates
- 7 Oct 2020to 16 Oct 2027
- 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
- Breast-conserving surgery.
- Imaging diagnosis as the only breast tumor focus according to mammography, breast ultrasound and/or nuclear magnetic resonance;
- Pathological diagnosis of carcinoma in situ or infiltrating
- Oncoplastic without associated flaps;
Who cannot join
- Male patients;
- Patients with a history of ipsilateral breast cancer.
- Oncoplastic that includes flaps
- Multifocality or multicentricity;
- Pregnant or lactating patient;
- Stage IV patients;
- Patients eligible for mastectomy;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Amparo Garcia-Tejedor, MDPhD, 0034-932607695, agarciat@bellvitgehospital.cat
About this study
Official title: Reduction of Affected Margins in Conservative Surgery for Breast Cancer: Impact of Systematic Shaving in the Operating Room
The objective of this clinical trial is to demonstrate the reduction of positive margins in the definitive pathology of patients undergoing breast-conserving surgery with the systematic shaving technique compared to conventional surgery, and the reduction of second interventions for margin enlargement.
Read the detailed description
Patients with breast cancer who undergo breast-conserving surgery are randomized in the operating room after lumpectomy into 2 groups of 117 patients each: shaving/no-shaving (standard surgery).
- Conditions
- Margin, Tumor-Free, Breast Cancer, Surgery
- Being tested
- Margin shaving
- Medical subject headings
- Margins of Excision, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Margin shavingProcedure or surgery
In both cohorts, an intraoperative study of the margins will be carried out, and enlargement of those margins that are affected will be carried out as indicated by the pathologist. Subsequently, shaving is performed in case of being randomized to the study group or surgery is completed in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Shaving | Experimental | Subsequent to lumpectomy, a circumferential enlargement of all lumpectomy margins, including lateral, medial, superior, inferior, anterior, and posterior, approximately 5-10mm thick, will be resected. Receives: Procedure: Margin shaving |
| No Shaving | Active comparator | Standard lumpectomy Receives: Procedure: Margin shaving |
What is being measured
The primary outcome is the main question the study is designed to answer.
Margin involvement
To compare the number of cases with affected margins in the definitive pathological anatomy, of the cases with intraoperative systematic shaving versus the group of no shaving
Measured: 3 weeks after each surgery
Re-interventions
Demonstrate the reduction of second surgeries to widen affected margins in breast conserving surgery with the shaving technique
Measured: 3 weeks after each surgery
Secondary outcomes (1)
Shaving versus intraoperative pathological study
Assess the possibility of replacing the intraoperative study of the margins with systematic shaving
Measured: 3 weeks after each surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start7 Oct 2020
- Primary completion16 Jun 2027 (estimated)
- Study completion16 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Margin, Tumor-FreeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amparo Garcia-Tejedor, Hospital Universitari de Bellvitge
- Investigators
- Amparo Garcia Tejedor, MDPhD, Principal investigator, Hospital de Bellvitge. Instituto de Investigación Biomédica de Bellvitge (IDIBELL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782686
- Sponsor's protocol ID
- PR275/20
- Status last verified
- Sep 2026
- First submitted
- 11 Mar 2023
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Affected Margins in Conservative Surgery for Breast Cancer: Impact of Systematic Shaving in the Operating Room
- ClinicalTrials.gov ID
- NCT05782686
- Acronym / sponsor ID
- PR275/20
- Conditions
- Margin, Tumor-Free, Breast Cancer, Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 16 Jun 2027 (estimated)
- Study completion
- 16 Oct 2027 (estimated)
- First posted
- 23 Mar 2023 (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.
The objective of this clinical trial is to demonstrate the reduction of positive margins in the definitive pathology of patients undergoing breast-conserving surgery with the systematic shaving technique compared to conventional surgery, and the reduction of second interventions for margin enlargement.
Detailed description
Patients with breast cancer who undergo breast-conserving surgery are randomized in the operating room after lumpectomy into 2 groups of 117 patients each: shaving/no-shaving (standard surgery).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Shaving | Experimental | Procedure: Margin shavingSubsequent to lumpectomy, a circumferential enlargement of all lumpectomy margins, including lateral, medial, superior, inferior, anterior, and posterior, approximately 5-10mm thick, will be resected. |
| No Shaving | Active comparator | Procedure: Margin shavingStandard lumpectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Breast-conserving surgery.
- Imaging diagnosis as the only breast tumor focus according to mammography, breast ultrasound and/or nuclear magnetic resonance;
- Pathological diagnosis of carcinoma in situ or infiltrating
- Oncoplastic without associated flaps;
Key exclusion criteria (7 listed)
- Male patients;
- Patients with a history of ipsilateral breast cancer.
- Oncoplastic that includes flaps
- Multifocality or multicentricity;
- Pregnant or lactating patient;
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 |
|---|---|---|
| Margin shavingIn both cohorts, an intraoperative study of the margins will be carried out, and enlargement of those margins that are affected will be carried out as indicated by the pathologist. Subsequently, shaving is performed in case of being randomized to the study group or surgery is completed in the control group. | Procedure or surgery | No Shaving, Shaving |
Primary outcome
Margin involvement
Time frame: 3 weeks after each surgery
To compare the number of cases with affected margins in the definitive pathological anatomy, of the cases with intraoperative systematic shaving versus the group of no shaving
Re-interventions
Time frame: 3 weeks after each surgery
Demonstrate the reduction of second surgeries to widen affected margins in breast conserving surgery with the shaving technique
1 secondary outcome
Shaving versus intraoperative pathological study
Time frame: 3 weeks after each surgery
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 17 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Margin, Tumor-Free
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
Active, not recruitingPhase 3
A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Carcinoma, Renal Cell
Active, not recruitingPhase 1/2
Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer
RecruitingPhase 2
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Metastatic Melanoma, Advanced Locoregional Melanoma
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.
Amparo Garcia Tejedor, MDPhD principal investigator
Hospital de Bellvitge. Instituto de Investigación Biomédica de Bellvitge (IDIBELL)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Margin shaving in people with Margin, Tumor-Free and Breast Cancer, run by Hospital Universitari de Bellvitge at 1 site in Spain.
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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. 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 Spain. 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 amparo garcia-tejedor, MDPhD (932607695, agarciat@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Margin involvement (time frame: 3 weeks after each surgery). The study lists 2 primary outcomes in all. 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 17 Sep 2026.