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NCT06153836 · ClinicalTrials.gov registry record · Phase 2
Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction
A Phase 2 study of Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IIA Breast Cancer AJCC v8, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06153836 is a Phase 2 study of Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IIA Breast Cancer AJCC v8 that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 20 participants, below the 293-participant average among 63 other Anatomic Stage I Breast Cancer AJCC v8 trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06153836, a Phase 2 study of Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IIA Breast Cancer AJCC v8, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial tests the willingness of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized study of NSM with or without neurotization of the nipple areolar complex (NAC). This trial also compares patient reported outcomes, including quality of life and breast and NAC sexual functionality, for patients undergoing NSM with or without neurotization of the NAC. NSM is a standard practice option for patients undergoing preventative mastectomy, but many report dissatisfaction with decreased nipple sensation. Neurotization is a surgical technique using a nerve graft in an attempt to restore NAC sensation. Neurotization during NSM and reconstruction may restore NAC sensation and improve quality of life in breast cancer patients.
Conditions Studied
Interventions
- OTHER Questionnaire Administration
- PROCEDURE Neurotization Procedure
- PROCEDURE Subcutaneous Mastectomy
Study Locations (1)
Florida
- Mayo Clinic in Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-12-05 |
| Est. Completion | 2026-11-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06153836
The ClinicalTrials.gov registry entry for NCT06153836 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 293-participant average among 63 other Anatomic Stage I Breast Cancer AJCC v8 trials with a reported enrollment target (93% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Anatomic Stage I Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Questionnaire Administration is the first listed.
NCT06153836 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT06153836 about?
NCT06153836 is a clinical study titled "Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction". This phase II trial tests the willingness of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized study of NSM with or without neurotization of the nipple areolar complex (NAC). This trial also compares patient reported outcomes, including quality of life and breast and NAC ...
What is the current status of trial NCT06153836?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2023-12-05. Estimated completion is 2026-11-10.
What conditions does trial NCT06153836 study?
This clinical trial studies the following conditions: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage 0 Breast Cancer AJCC v8.
What interventions are being tested in trial NCT06153836?
The interventions under investigation include: Questionnaire Administration (OTHER), Neurotization Procedure (PROCEDURE), Subcutaneous Mastectomy (PROCEDURE).
Who is sponsoring clinical trial NCT06153836?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06153836 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.