Non-melanoma Skin Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONSRT-100
The SRT-100™ is a simple painless non-invasive in-office procedure that is approved by the U.S. Food and Drug Administration (U.S. FDA) to treat keloids caused by surgery or injury by delivering a precise, calibrated dose of Superficial Radiation Therapy (SRT) that only goes skin deep.
Sponsors
Sensus Healthcare
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* 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.
Exclusion criteria
* Lesions of etiology other than non-melanoma skin cancer (NMSC)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cure Rate | 5 years | NMSC cure rate will be calculated as the percentage of lesions that attained complete cure following SRT-100 treatment completion. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-Melanoma Skin Cancers (NMSCs) Non-Melanoma Skin Cancers (NMSCs) treated with SRT-100 therapy. | 516 |
| Total | 516 |
Baseline characteristics
| Characteristic | Non-Melanoma Skin Cancers (NMSCs) |
|---|---|
| Age, Continuous | 78.94 years STANDARD_DEVIATION 8.89 |
| Ethnicity (NIH/OMB) Participant Race Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Participant Race Not Hispanic or Latino | 516 Participants |
| Ethnicity (NIH/OMB) Participant Race Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 516 Participants |
| Sex: Female, Male Female | 223 Participants |
| Sex: Female, Male Male | 293 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 776 |
| other Total, other adverse events | 6 / 776 |
| serious Total, serious adverse events | 0 / 776 |
Outcome results
Primary
Cure Rate
NMSC cure rate will be calculated as the percentage of lesions that attained complete cure following SRT-100 treatment completion.
Time frame: 5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Non-Melanoma Skin Cancers (NMSCs) | Cure Rate | 751 lesions |