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NCT04595435 · ClinicalTrials.gov registry record
IORT-Breast at Medical Center Navicent Health
A clinical trial of Breast Cancer Female and Early Stage Breast Cancer, sponsored by Wake Forest University Health Sciences.
- Active
- Registry status
- 94
- Enrollment target
- 1
- Study location
NCT04595435 is a study of Breast Cancer Female and Early Stage Breast Cancer that is active but no longer recruiting, run by Wake Forest University Health Sciences. The registered enrollment target is 94 participants, below the 691-participant average among 46 other Breast Cancer Female trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04595435, a study of Breast Cancer Female and Early Stage Breast Cancer, is active but no longer recruiting, sponsored by Wake Forest University Health Sciences.
- ACTIVE NOT RECRUITING
- Registry status
- 94 participants
- Enrollment target
- 1
- Study location
Study Summary
Intraoperative Breast Radiation Therapy (IORT-Breast) utilizing the Xoft Axxent Electronic Brachytherapy System (Xoft) has been recently introduced as a treatment option for women 50 years of age and older who have early stage, low risk Invasive Breast Cancer (IBC). Clinical trials have shown IORT to be non-inferior to whole breast radiation, however some concern continues with rates of recurrence and clinical outcomes. Given the recent introduction and continued debate it is an excellent opportunity to observe and monitor outcomes in the patients that are treated at Navicent Health through this prospective, observational registry. The opportunity also permits examination of the participant's thoughts and feeling on Quality of Life and Cosmetic Appearance
Conditions Studied
Interventions
- PROCEDURE Lumpectomy
- RADIATION Intraoperative Radiation Therapy
Study Locations (1)
Georgia
- Medical Center, Navicent Health - Macon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2019-03-19 |
| Est. Completion | 2033-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04595435
The ClinicalTrials.gov registry entry for NCT04595435 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 691-participant average among 46 other Breast Cancer Female trials with a reported enrollment target (86% lower). The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Breast Cancer Female appearing as the primary indexed condition, and to 2 interventions - of which Lumpectomy is the first listed.
NCT04595435 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.
Frequently Asked Questions
What is clinical trial NCT04595435 about?
NCT04595435 is a clinical study titled "IORT-Breast at Medical Center Navicent Health". Intraoperative Breast Radiation Therapy (IORT-Breast) utilizing the Xoft Axxent Electronic Brachytherapy System (Xoft) has been recently introduced as a treatment option for women 50 years of age and older who have early stage, low risk Invasive Breast Cancer (IBC). Clinical trials have shown IORT t...
What is the current status of trial NCT04595435?
This trial is currently active not recruiting. The enrollment target is 94 participants. The study started on 2019-03-19. Estimated completion is 2033-12-31.
What conditions does trial NCT04595435 study?
This clinical trial studies the following conditions: Breast Cancer Female, Early Stage Breast Cancer.
What interventions are being tested in trial NCT04595435?
The interventions under investigation include: Lumpectomy (PROCEDURE), Intraoperative Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT04595435?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04595435 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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