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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: Active study of Breast Cancer Female and Early Stage Breast Cancer, sponsored by Wake Forest University Health Sciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
To determine rate of recurrence of disease at specific time period
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 |
What the registry record for NCT04595435 still lists
NCT04595435 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 691-participant average among 46 other Breast Cancer Female trials with a reported enrollment target (86% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Breast Cancer Female
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04595435's enrollment target sits among peer trials
94 25th of 46 higher than 22 of 46 other Breast Cancer Female trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer Female trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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