Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-01-05 @ 6:15 PM
Study NCT ID:
NCT06926335
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-17
First Post:
2025-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oncological Safety of Oncoplastic Breast Surgery in Multicentric Breast Cancer
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
Oncological Safety of Oncoplastic Breast Surgery in Multicentric Breast Retrospective Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate Oncological safety of oncoplastic breast surgery in multicentric breast cancer
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: