The purpose of this retrospective-prospective study is to evaluate lesions after treatment for BCC or SCC NMSC in order to gain a better understanding of the durability of the treatment, and risk of late toxicities for this patient population.
This is a retrospective-prospective study design. The study is post-market, on-label observational study for the treatment of NMSC. Patients who completed treatment at least five years from the last treatment will be identified and existing data as required by this protocol in the patient's record will be collected in addition to conducting office visits or telehealth visits (video) for long-term follow-up. The study will include: Identifying patients, retrospectively, who completed treatment a minimum of five years from the last treatment. The history and demographic data will be collected from up to 300 subjects previously treated with eBx for the treatment of NMSC. Patients will have an office visit or telehealth visit in order for the investigators to assess the lesion site, document absence of recurrence, treatment for recurrence (if applicable), and long-term toxicities at the time of the prospective visit.
Study Type
OBSERVATIONAL
Enrollment
183
The Xoft Axxent Electronic Brachytherapy (eBx) System allows for the administration of high dose rate brachytherapy treatments using an electronic source
Kenneth A. Miller, MD Dermatology
Campbell, California, United States
Dermatology & Laser Center of San Diego
San Diego, California, United States
Local Recurrence
Physician office visit for long-term assessment to determine if recurrence of skin cancer has occurred at previously treated site for subjects who were previously treated at least 5 years prior; Subjects treated with Xoft eBx or MMS over 5 years prior were called in for a long-term prospective visit, reconsented, and assessed for skin cancer recurrence at the previously treated site.
Time frame: Retrospective review of subject's post Xoft eBx or MMS treatment completed 5-10 years ago, data assessed during a 1-day long-term prospective clinic visit by study completion.
Skin Toxicities
Assessment of treatment site at a long-term follow-up visit conducted at 5 years or greater post treatment to determine if late toxicities have occurred at the previously treated site where either eBx or Mohs was performed. Subjects treated with Xoft eBx or MMS over 5 years prior were called in for a long-term prospective visit, reconsented, and assessed for late toxicities at the previously treated site.
Time frame: Retrospective review of subject's post Xoft eBx or MMS treatment completed 5-10 years ago, data assessed during a 1-day long-term prospective clinic visit by study completion.
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