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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Xoft, Inc.
- 入组人数
- 369
- 试验地点
- 4
- 主要终点
- Absence of Local Recurrence at Treatment Site(s) Greater or Equal to 3 Years Follow-up
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 41 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
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
结局指标
主要结局
Absence of Local Recurrence at Treatment Site(s) Greater or Equal to 3 Years Follow-up
时间窗: Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.
Subjects treated with Xoft eBx or MMS over 3 years prior were called in for a long-term prospective visit, consented, and assessed for skin cancer recurrence at the previously treated site.
次要结局
- Comparison of Late Toxicities Related to eBx vs. Mohs Treatment Using A Chronic Toxicity Questionnaire Based on Physician Assessment at Long-term Prospective Visit(Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.)
- Comparison of Long-term Cosmetic Outcomes for Lesions Treated for NMSC With eBx vs. Mohs(Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.)
- Chronic Toxicities(Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start at1 long-term prospective visit by study completion.)
- Patient Survey for Reporting Patient Reported Outcomes (PRO)(Range greater or equal to 3 years post last Xoft eBx or MMS treatment at the time of study start, with 1 long-term prospective visit by study completion.)