This is a retrospective-prospective study design. Patients who completed treatment approximately 3 years (range of 2-4 years) at time of IRB approval of this study will be identified and any existing data in the patient's record will be collected in addition to conducting office visits for long-term follow-up.
This is a retrospective-prospective study design. Patients who completed treatment approximately 3 years (range of 2-4 years) at time of IRB approval of this study will be identified and any existing data in the patient's record will be collected in addition to conducting office visits for long-term follow-up. The study will include 2 parts: 1. Retrospective chart review: Collect data from patient records who completed treatment a minimum of 2 years prior to study onset and determine the feasibility of doing a matched pair cohort study comparison of eBx versus Mohs surgery. The history, demographic and treatment data will be retrospectively collected from up to 320 subjects previously treated with eBx for the treatment of NMSC and up to 320 subjects previously treated with Mohs surgery for the treatment of NMSC. 2. Prospective Follow-up: Patients will return for long-term follow-up visits for the investigators to assess the lesion site, document absence of recurrence/ absence of recurrence, toxicities, and collect patient reported outcomes.
Study Type
OBSERVATIONAL
Enrollment
369
A group receives High-dose-rate electronic brachytherapy (EBT) which provides a non-surgical treatment option and the other group receives Mohs surgery. This matched-pair cohort study compared the outcomes of treatment with EBT to those of Mohs surgery in patients with NMSC.
Kenneth A. Miller, PC
Los Gatos, California, United States
Dermatology & Laser Center of San Diego
San Diego, California, United States
Dermatology and Laser Center of San Diego
San Diego, California, United States
Strimling Laser and Vein Institute
Las Vegas, Nevada, United States
Absence of Local Recurrence at Treatment Site(s) Greater or Equal to 3 Years Follow-up
Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed for skin cancer recurrence at the previously treated site.
Time frame: Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.
Comparison of Late Toxicities Related to eBx vs. Mohs Treatment Using A Chronic Toxicity Questionnaire Based on Physician Assessment at Long-term Prospective Visit
Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed to determine if late toxicities occurred at the previously treated site with Xoft eBx or MMS.
Time frame: Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.
Comparison of Long-term Cosmetic Outcomes for Lesions Treated for NMSC With eBx vs. Mohs
Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and an assessment of cosmetic outcome occurred at the previously treated site with Xoft eBx or MMS.
Time frame: Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.
Chronic Toxicities
Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed to determine if there were any chronic toxicities found at the previously treated site with Xoft eBx or MMS.
Time frame: Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.
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Patient Survey for Reporting Patient Reported Outcomes (PRO)
Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, then subjects completed a Patient Satisfaction Score: min=0, max=60, with 60 as the maximum positive or favorable response.
Time frame: Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start, with 1 long-term prospective visit by study completion.