Back to resultsImpact of Systematic Shaving on Margins
Primary Purpose
Margin, Tumor-Free, Breast Cancer, Surgery
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Margin shaving
Sponsored by
About this trial
This is an interventional treatment trial for Margin, Tumor-Free
Eligibility Criteria
Inclusion Criteria: 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; Exclusion Criteria: 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;
Sites / Locations
- Hospital de BellvitgeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Shaving
No Shaving
Arm Description
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.
Standard lumpectomy
Outcomes
Primary Outcome Measures
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
Re-interventions
Demonstrate the reduction of second surgeries to widen affected margins in breast conserving surgery with the shaving technique
Secondary Outcome Measures
Shaving versus intraoperative pathological study
Assess the possibility of replacing the intraoperative study of the margins with systematic shaving
Full Information
NCT ID
NCT05782686
First Posted
March 11, 2023
Last Updated
August 11, 2023
Sponsor
Hospital Universitari de Bellvitge
1. Study Identification
Unique Protocol Identification Number
NCT05782686
Brief Title
Impact of Systematic Shaving on Margins
Official Title
Reduction of Affected Margins in Conservative Surgery for Breast Cancer: Impact of Systematic Shaving in the Operating Room
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
June 16, 2024 (Anticipated)
Study Completion Date
October 16, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitari de Bellvitge
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Margin, Tumor-Free, Breast Cancer, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
ParticipantInvestigator
Masking Description
Randomization will be performed by another investigator outside the operating room after lumpectomy.
Allocation
Randomized
Enrollment
234 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Shaving
Arm Type
Experimental
Arm Description
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.
Arm Title
No Shaving
Arm Type
Active Comparator
Arm Description
Standard lumpectomy
Intervention Type
Procedure
Intervention Name(s)
Margin shaving
Intervention Description
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.
Primary Outcome Measure Information:
Title
Margin involvement
Description
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
Time Frame
3 weeks after each surgery
Title
Re-interventions
Description
Demonstrate the reduction of second surgeries to widen affected margins in breast conserving surgery with the shaving technique
Time Frame
3 weeks after each surgery
Secondary Outcome Measure Information:
Title
Shaving versus intraoperative pathological study
Description
Assess the possibility of replacing the intraoperative study of the margins with systematic shaving
Time Frame
3 weeks after each surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Exclusion Criteria:
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
amparo garcia-tejedor, MDPhD
Phone
932607695
Email
agarciat@bellvitgehospital.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amparo Garcia Tejedor, MDPhD
Organizational Affiliation
Hospital de Bellvitge. Instituto de Investigación Biomédica de Bellvitge (IDIBELL)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amparo Garcia-Tejedor, MDPhD
Phone
0034-932607695
Email
agarciat@bellvitgehospital.cat
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Systematic Shaving on Margins
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