Electronic Brachytherapy (eBx)-Mohs Matched Pair - Cohort Study A Multi-Center Retrospective-Prospective Matched Pairs Cohort Study to Assess Long-term Clinical Outcomes of Non-melanoma Skin Cancer Patients Treated With eBx Compared to Non-melanoma Skin Cancer Patients Treated With Mohs Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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: 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. 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.

Official Title
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Electronic Brachytherapy (eBx)-Mohs Matched Pair - Cohort Study A Multi-Center Retrospective-Prospective Matched Pairs Cohort Study to Assess Long-term Clinical Outcomes of Non-melanoma Skin Cancer Patients Treated With eBx Compared to Non-melanoma Skin Cancer Patients Treated With Mohs Surgery

Conditions
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Nonmelanoma Skin Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System or Mohs surgery; Provides informed Consent; Greater than 40 years of age; Pathological diagnosis confirmed to be squamous cell or basal cell carcinoma prior to treatment; Cancer Staging included in this study: Stage 0: Tis, N0, M0 Stage 1: T1, N0, M0 Stage 2: T2, N0, M0 and ≤ 4cm in diameter Exclusion Criteria: Target area is adjacent to a burn scar Any prior definitive surgical resection of the cancer, prior to Radiation Treatment Known perineural invasion Actinic Keratosis Known spread to regional lymph nodes Known metastatic disease

Ages Eligible for Study
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Minimum Age: 41 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Electronic Brachytherapy<br>Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System | |
| Mohs Surgery<br>Previously completed treatment for non-melanoma skin cancer using Mohs Surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of local recurrence at approximately 3 to 5-year follow-up (range is approximately two to five years) at treatment site(s). | Assessment of treatment site 2-5 years following treatment to determine if recurrence | Two to five years post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of long-term toxicities related to eBx vs. Mohs treatment Using A Chronic Toxicity Questionnaire Based om Physician Assessment at Time of Visit | Assessment of treatment site 2-5 years following treatment to determine if long-term toxicity | Two to five years post treatment | 
| Comparison of long-term cosmetic outcomes for lesions treated for NMSC with eBx vs. Mohs; | Physician assessment of cosmetic outcome two to five years post treatment, at time of clinic visit. | Two to five years post treatment | 
| Chronic toxicities | Physician assessment of treatment site to assess for chronic toxicites two to five years post treatment, at time of clinic visit. | Two to five years post treatment | 
| Patient Survey for reporting Patient Reported Outcomes (PRO) | Patient completes a survey at a clinic visit two to five years post treatment at time of clinic visit | Two to five years post treatment |