跳至主要内容
临床试验/NCT03693937
NCT03693937已完成不适用

A Retrospective Registry Study to Evaluate the Long-Term Efficacy and Safety of Superficial Radiation Therapy (SRT) in Individuals With Non-Melanoma Skin Cancer (NMSC) .

Sensus Healthcare1 个研究点 分布在 1 个国家目标入组 776 人开始时间: 2018年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
776
试验地点
1
主要终点
Cure Rate

研究概览

简要总结

Non-Melanoma Skin Cancer (NMSC) is the most commonly occurring type of skin cancer, and predominantly comprises (98%) Basal Cell Carcinomas (BCC) and Squamous Cell Carcinomas (SCC). About 3.3 million people in the United States (U.S.) are diagnosed with NMSC annually, equating about 5.4 million BCCs and SCCs. Low-dose Superficial Radiation Therapy (SRT) effectively destroys BCC and SCC without any invasive cutting, bleeding or stitching. There is no need for anesthesia, no risk of infection or scarring and no need for reconstructive plastic surgery. Healing time is quick with minimal to no post-treatment downtime or lifestyle restrictions. It is therefore both a viable and highly desirable alternative to invasive, painful and higher-risk surgical procedures. This study will utilize retrospective chart analysis to evaluate the outcomes of SRT-100™ therapy on NMSC lesions over a long-term post-treatment period.

详细描述

Non-Melanoma Skin Cancer (NMSC) is the most commonly occurring type of skin cancer and accounts for about one-third of all cancers. NMSCs predominantly (98%) include Basal Cell Carcinomas (BCC) and Squamous Cell Carcinomas (SCC). Basal cell carcinomas (BCC) are abnormal, uncontrolled growths or lesions that arise in the skin's basal cells that line the deepest layer of the epidermis, occurring most commonly on sun-exposed areas of the face, head and neck. They are slow-growing cancers that rarely metastasize. Delayed or ineffective treatment of BCCs can lead to disfigurement of the lesion and recurrence. Squamous cell carcinomas (SCC) are uncontrolled growths of abnormal cells arising from the squamous cells in the epidermis producing keratin, also typically developing on sun-exposed and damaged body areas such as the face, ears, neck, lips, back of the hands, arms and legs. SCCs may be slow or rapidly growing with significant tenderness and pain and may become disfiguring and fatal if left untreated and allowed to grow.

About 3.3 million people in the United States (U.S.) are diagnosed with NMSC annually, equating about 5.4 million BCCs and SCCs. Diagnosis and treatment of NMSC in the U.S. increased by 77% between 1994 and 2014. The incidence of BCC is about 4 times that of SCC. An estimated 4.3 million cases of BCC are diagnosed annually in the U.S. resulting in over 3,000 deaths. Over 1 million cases of SCC are diagnosed in the U.S. annually, resulting in over 15,000 deaths. SCC has a 4% annual incidence of metastasis. About 90% of NMSC is associated with repeated and unprotected skin exposure to ultraviolet (UV) rays

Treatment options for NMSC include surgery, cryotherapy, curettage and electrodesiccation, radiation therapy including superficial radiation therapy (SRT), photodynamic therapy, various forms of brachytherapy, and chemotherapeutic agents.

Low-dose SRT effectively destroys BCC and SCC without any invasive cutting, bleeding or stitching. There is no need for anesthesia, no risk of infection or scarring and no need for reconstructive plastic surgery. Healing time is quick with minimal to no post-treatment downtime or lifestyle restrictions. It is therefore both a viable and highly desirable alternative to invasive, painful and higher-risk surgical procedures. This study will utilize retrospective chart analysis to evaluate the outcomes of SRT-100™ therapy on NMSC lesions over a long-term post-treatment period.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Treatment with SRT-100™.
  • Treatment date of December 31, 2015 or earlier.
  • Non-Melanoma Skin Cancer (NMSC) pathological diagnosis of confirmed squamous cell carcinoma (SCC) or basal cell carcinoma (BCC).
  • Histopathological Grade: G1 (well differentiated); G2 (moderately differentiated) or Gx (not assessed).
  • One lesion is treated, or more than one lesion is treated with a minimum of a 5 mm gap between the edges of the lesion margins.
  • Required retrospective data is existing and sufficient.

排除标准

  • Lesions of etiology other than non-melanoma skin cancer (NMSC)

结局指标

主要结局

Cure Rate

时间窗: 5 years

NMSC cure rate will be calculated as the percentage of lesions that attained complete cure following SRT-100 treatment completion.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验