- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06926335
Oncological Safety of Oncoplastic Breast Surgery in Multicentric Breast Cancer
Oncological Safety of Oncoplastic Breast Surgery in Multicentric Breast Retrospective Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Breast cancer is the most prevalent cancer in women worldwide, accounting for about 23.8%. Multifocal and multicentric breast tumors are defined as two or more neoplasms separated in one breast. In multifocal tumors, a quarter of the breast is involved while in multicentric tumors, two quarters or more are involved. There is no exact radiological definition, but the distance between the multifocal tumors is less than or equal to 5 cm, whereas the distance between multicentric tumors is 5 cm, or more.
Due to increasingly use of more developed imaging methods such as tomosynthesis, magnetic resonance imaging (MRI) in these patients, we face more MF/MC breast cancer cases. It is seen that MF/MC breast cancer incidence ranges from 6% to 75% in different series.
Breast-conserving surgery (BCS) and radiotherapy have been adopted as the main treatment methods for early breast cancer. However, there are some studies stating that BCS carries risks for local recurrence in patients with MF/MC breast cancer.
Oncoplastic breast conservation (OBC) relies on applying plastic surgery principles within the context of sound oncological resection. Volume-reducing or volume- replacing methods are utilised to optimise postoperative appearances whilst prioritizing negative margin resection, supported by prompt adjuvant therapy. In fact, it is agreed that in cases where more than 20% of the breast tissue must be excised for oncological margin clearance, oncoplastic surgery is likely to require more complex techniques.This may allow larger specimens to be resected than in traditional breast conservation surgery, but with comparable histopathological properties to those who would be offered mastectomy.
Previous work has suggested that as such, OBC should be regarded as a separate entity from breast conservation therapy, and that direct comparison with mastectomy outcomes should be performed to inform decision-making amongst clinicians and with patients when planning for surgery.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Assuit, Egypt
- Assuit University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Female patients with multicentric breast cancer
- Female Patient aged from 18 to 65 years old
- Patients who are fit for general anesthesia.
- Patients who provide a written informed consent.
- Patient who agree to provide short term outcome data and agree to provide contact information to provide contact information
Exclusion Criteria:
- Female patients less than 20 years old
- Stage 4 breast cancer
- Patients who are contraindicated for radiotherapy
- Pregnant patients in first trimester
- Patient with inflammatory carcinoma
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To evaluate Oncological safety of oncoplastic breast surgery in multicentric breast cancer
Time Frame: 5 years
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Number of multicentric breast cancer who underwent breast conservative surgery with no recurrance
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5 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Breast conserve
Drug and device information, study documents
product manufactured in and exported from the U.S.
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