Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04603209
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2020-10-21
Brief Title:
Registry for Intra-Operative Radiotherapy During Breast Conserving Surgery in Patients With Early Stage Breast Cancer
Sponsor:
Saint Johns Cancer Institute
Organization:
Saint Johns Cancer Institute
Study Overview
Official Title:
Research Registry for Intra-Operative Radiotherapy IORT During Breast Conserving Surgery in Patients With in Situ and Early Stage Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-04
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:
This is a prospective registry study that will enroll all women with early stage breast cancer who will be treated with intraoperative radiotherapy IORT during breast-conserving surgery The purpose of this study is to further validate the long-term effectiveness and safety of this treatment method We aim to assess short and long-term patient outcomes associated with IORT including perioperative complications local and distance disease recurrences as well as disease-free survival and overall survival
Detailed Description:
At Providence Saint Johns Health Center there is the ongoing integration of Intra-Operative Radiation Therapy IORT as a standard treatment option among Breast Conserving Therapy BCT for individuals with in situ and early stage breast cancer Currently approximately 60 women per year are being treated with IORT No repository of information of patient outcomes with this treatment has been established This leaves a critical gap in the ability to assess the long-term outcomes of patients treated with IORT
As the practice of using IORT to treat early stage and in situ breast cancer continues to grow at Providence Saint Johns Health Center this registry will provide the data needed to compare patient outcomes with those being treated with the traditional whole breast radiation therapy In addition the Providence Health Services strives to improve patient care and outcomes with excellence whenever possible The registry will provide the data needed to compare patient outcomes to national and community standards that can inform internal practice patterns and contribute to advancing breast cancer care nationally and internationally
As the practice of using IORT to treat early stage and in situ breast cancer continues to grow at Providence Saint Johns Health Center this registry will provide the data needed to compare patient outcomes with those being treated with the traditional whole breast radiation therapy In addition the Providence Health Services strives to improve patient care and outcomes with excellence whenever possible The registry will provide the data needed to compare patient outcomes to national and community standards that can inform internal practice patterns and contribute to advancing breast cancer care nationally and internationally
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