Status:
COMPLETED
Post-market Multi-Center RETRO-Prospective Study to Assess Long-term Clinical Outcomes NMSC Patients Treated With eBx
Lead Sponsor:
Xoft, Inc.
Conditions:
Non-melanoma Skin Cancer
Eligibility:
All Genders
40+ years
Brief Summary
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 l...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- Previously completed treatment for non-melanoma skin cancer using Xoft eBx Electronic Brachytherapy System according to standard of care;16
- Provides informed consent;
- Greater than 40 years of age;
- Pathological diagnosis confirmed to be squamous cell carcinoma, or squamous cell carcinoma-in-situ, or basal cell carcinoma prior to treatment;
- Cancer Staging included in this study:
- Stage 0: Tis, N0, M0 Stage 1: T1a, b, c, N0, M0 Stage 2: T2a, N0, M0
Exclusion
- 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;
- Lesion treated with Mohs surgery.
Key Trial Info
Start Date :
March 9 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 13 2022
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT05257486
Start Date
March 9 2022
End Date
October 13 2022
Last Update
January 13 2025
Active Locations (2)
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1
Kenneth A. Miller, MD Dermatology
Campbell, California, United States, 95032
2
Dermatology & Laser Center of San Diego
San Diego, California, United States, 91910