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Could a simple shave during breast surgery save women from going under the knife again?

NCT ID NCT05782686

Disease control Sponsor: Hospital Universitari de Bellvitge Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study tests a technique called systematic margin shaving during breast-conserving surgery for breast cancer. The idea is to remove a thin extra layer of tissue around the tumor right after the main lump is taken out, based on a pathologist's check. Researchers want to see if this lowers the number of cases where cancer cells are found at the edge of the removed tissue (positive margins), which often means a second surgery. About 234 women having breast-conserving surgery will be randomly assigned to either get the extra shaving or standard surgery alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
margin shaving procedure
What this could lead to
If successful, this technique could reduce the need for a second surgery after breast-conserving cancer treatment.
What could go wrong
This is a moderate-sized trial testing a surgical technique, not a new drug. The benefit may be small or not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 234 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2020

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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;

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Margins of Excision

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer Margin, tumor-free Surgery

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital de Bellvitge

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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