Post-market Multi-Center RETRO-Prospective Study to Assess Long-term Clinical Outcomes NMSC Patients Treated With eBx
A Post-market Multi-Center Retrospective-Prospective Study to Assess Long-term Clinical Outcomes of Non-melanoma Skin Cancer Patients Treated With eBx
研究概览
详细说明
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.
研究类型
注册 (预期的)
联系人和位置
学习地点
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California
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Campbell、California、美国、95032
- Kenneth A. Miller, MD Dermatology
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San Diego、California、美国、91910
- Dermatology & Laser Center of San Diego
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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:
Stage 0: Tis, N0, M0 Stage 1: T1a, b, c, N0, M0 Stage 2: T2a, N0, M0
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.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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NMSC Treatment
Patients who completed Xoft eBx treatment at least five years from the last treatment.
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The Xoft Axxent Electronic Brachytherapy (eBx) System allows for the administration of high dose rate brachytherapy treatments using an electronic source
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Local Recurrence
大体时间：Range of 5-10 years post last eBx treatment
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Absence of local recurrence at ≥ 5-year follow-up by physician assessment at treatment site(s).
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Range of 5-10 years post last eBx treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Skin Toxicities
大体时间：Range of 5-10 years post last eBx treatment
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Occurrence of long-term skin toxicities by physician assessment.
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Range of 5-10 years post last eBx treatment
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合作者和调查者
赞助
调查人员
- 首席研究员：Stephen Doggett, MD、Mission Health
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Xoft eBx的临床试验
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Imperial College London尚未招聘急性髓性白血病 | 慢性粒单核细胞白血病 | 慢性粒细胞白血病 | 骨髓增生异常综合症 | 血统不明的急性白血病 | 急性淋巴细胞白血病英国
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Xoft, Inc.完全的