A Post-market Multi-Center Retrospective-Prospective Study to Assess Long-term Clinical Outcomes of Non-melanoma Skin Cancer Patients Treated With eBx
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Xoft, Inc.
- 入组人数
- 183
- 试验地点
- 2
- 主要终点
- Local Recurrence
研究概览
简要总结
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.
详细描述
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 treatment will be identified and existing data as required by this protocol in the patient's record will be collected in addition to conducting office visits or telehealth visits (video) for long-term follow-up.
The study will include:
Identifying patients, retrospectively, who completed treatment a minimum of five years from the last treatment. The history and demographic data will be collected from up to 300 subjects previously treated with eBx for the treatment of NMSC. Patients will have an office visit or telehealth visit in order for the investigators to assess the lesion site, document absence of recurrence, treatment for recurrence (if applicable), and long-term toxicities at the time of the prospective visit.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Local Recurrence
时间窗: 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.
Physician office visit for long-term assessment to determine if recurrence of skin cancer has occurred at previously treated site for subjects who were previously treated at least 5 years prior; Subjects treated with Xoft eBx or MMS over 5 years prior were called in for a long-term prospective visit, reconsented, and assessed for skin cancer recurrence at the previously treated site.
次要结局
- Skin Toxicities(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.)