NCT03024866

Comparison of eBX and Mohs Surgery for Treatment of Early-stage Non-melanoma Skin Cancer a 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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 369 (actual)
• Sponsor: Xoft, Inc. · Industry
• Sex: All
• Age: 41 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Nonmelanoma Skin Cancer

Interventions

Type	Name	Description
PROCEDURE	Electronic Brachytherapy	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.

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2017-01-19
• Last updated: 2025-02-06
• Results posted: 2025-02-06

Locations

4 sites across 1 country: United States