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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: Recruiting Phase 2 study of Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IIA Breast Cancer AJCC v8, sponsored by Mayo Clinic.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Will calculate the proportion of eligible patients who opt to take part in the study. Additionally, will descriptively analyze and report the specific factors that influenced patients' decisions to participate, with the aim of identifying and addressing any obstacles encountered.
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 |
What NCT06153836 shows while recruiting
NCT06153836 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 293-participant average among 63 other Anatomic Stage I Breast Cancer AJCC v8 trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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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 NCT06153836's enrollment target sits among peer trials
20 59th of 63 higher than 5 of 63 other Anatomic Stage I Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage I Breast Cancer AJCC v8 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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