Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401590
Status:
COMPLETED
Last Update Posted:
2024-05-06
First Post:
2024-05-01
Brief Title:
Sensitivity and Predictive Value of Frozen Section of Sentinel Lymph Node Biopsy in Post Neoadjuvant Setting
Sponsor:
Aga Khan University
Organization:
Aga Khan University
Study Overview
Official Title:
Sensitivity and Predictive Value of Frozen Section of Sentinel Lymph Node Biopsy in Post Neoadjuvant Setting
Status:
COMPLETED
Status Verified Date:
2024-05
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:
Axillary lymph node status is one of the most important prognostic factors in primary breast carcinomas Sentinel lymph node biopsy has been increasing in post neoadjuvant setting when axillary nodes show good clinical and radiological response It allows to determine the axillary lymph node status which if negative saves the patient from axillary dissection AD and its potential complications To assess tumor response to neoadjuvant chemotherapy in the SLN pathological evaluation is the gold standard Response to neoadjuvant systemic therapy is an excellent predictor of outcome and achievement of pathological complete response PCR in the SLN is a prognostic predictor of long-term outcome with significantly better disease-free survival and overall survival Post-treatment isolated tumor cells ITCs and micro metastases predict worse survival compared with the same findings in the non-neoadjuvant setting Histologically partial response to therapy is characterized by small clusters and individual tumor cells set in hyaline stromal fibrosis Most false negative cases had metastatic foci identified exclusively on permanent sections and are not due to a true diagnostic interpretation error The timing of further axillary surgery immediate or a subsequent operation should be routinely discussed at centers using intraoperative assessment of the sentinel lymph nodes along with the potential for negative intraoperative findings and positive nodes on final pathology
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None