CompletedNot Applicable

Post-market Multi-Center RETRO-Prospective Study to Assess Long-term Clinical Outcomes NMSC Patients Treated With eBx

United States183 participantsStarted 2022-03-09

Plain-language 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 late toxicities for this patient population.

Who can participate

Age range40 Years

SexALL

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Inclusion criteria

✓. 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:

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;
✕. Lesion treated with Mohs surgery.

What they're measuring

Local Recurrence

Timeframe: 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.

Trial details

NCT IDNCT05257486

SponsorXoft, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-07-18

Results submitted2023-03-23

View on ClinicalTrials.gov More Non-melanoma Skin Cancer trials