Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505577
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-04
Brief Title:
Preoperative vs Pathologic Size in Breast Cancer A Prospective Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Concordance Between Preoperative Assessments and Pathologic Size Measurements in Breast Cancer a Prospective Observational Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Breast cancer the most prevalent malignancy among women globally is increasing in incidence While non-metastatic breast cancer requires surgery determining the optimal extent of resection remains challenging Inadequate resection margins necessitate reoperation leading to increased psychological stress costs and potentially compromised cosmetic outcomes and prognosis
Accurate preoperative assessment of resection extent is crucial and involves various factors including imaging studies physical examinations tumor molecular subtypes and intraductal carcinoma components This prospective observational study aims to identify and integrate multiple predictive factors to enhance surgical planning and minimize reoperation rates in breast cancer patients
Accurate preoperative assessment of resection extent is crucial and involves various factors including imaging studies physical examinations tumor molecular subtypes and intraductal carcinoma components This prospective observational study aims to identify and integrate multiple predictive factors to enhance surgical planning and minimize reoperation rates in breast cancer patients
Detailed Description:
Breast cancer is the most prevalent malignancy among women globally leading to surgical interventions for non-metastatic cases While breast cancer generally has a favorable prognosis achieving negative resection margins at initial surgery is crucial for optimal outcomes The challenge associated with accurately predicting the extent of resection preoperatively as failure to secure clear margins may necessitate further resection or total mastectomy resulting in increased psychological stress higher healthcare costs compromised cosmetic results and potential negative impacts on long-term prognosis and quality of life Many factors contribute to predicting the optimal resection extent including imaging studies physical examination findings tumor molecular subtypes presence and extent of intraductal carcinoma components etc Despite the availability of these predictive factors their integration and practical application in clinical decision-making remain challenging This prospective observational study aims to address this gap by analyzing the interplay of these factors in real-world clinical settings with the primary objective of deriving an integrated predictive model to guide surgeons in determining the optimal extent of resection preoperatively
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None