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A Retrospective Evaluation of Superficial Radiation Therapy (SRT) and Non-Melanoma Skin Cancer (NMSC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03693937
Recruitment Status : Completed
First Posted : October 3, 2018
Results First Posted : July 5, 2019
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Sensus Healthcare

Tracking Information
First Submitted Date October 1, 2018
First Posted Date October 3, 2018
Results First Submitted Date April 16, 2019
Results First Posted Date July 5, 2019
Last Update Posted Date July 5, 2019
Actual Study Start Date November 15, 2018
Actual Primary Completion Date March 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 16, 2019)
Cure Rate [ Time Frame: 5 years ]
NMSC cure rate will be calculated as the percentage of lesions that attained complete cure following SRT-100 treatment completion.
Original Primary Outcome Measures
 (submitted: October 1, 2018)
Cure rates following treatment completion. [ Time Frame: 5 years ]
Cure rate will be calculated as the percentage of lesions that attained complete cure following treatment completion.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Retrospective Evaluation of Superficial Radiation Therapy (SRT) and Non-Melanoma Skin Cancer (NMSC)
Official Title 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) .
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study population comprises patients who were treated with the SRT-100™ for one or more non-melanoma skin cancers (NMSCs) and have follow-up data.
Condition Non-melanoma Skin Cancer
Intervention Radiation: SRT-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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 16, 2019)
776
Original Estimated Enrollment
 (submitted: October 1, 2018)
100
Actual Study Completion Date March 16, 2019
Actual Primary Completion Date March 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03693937
Other Study ID Numbers SRTS-SRT-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Sensus Healthcare
Study Sponsor Sensus Healthcare
Collaborators Not Provided
Investigators
Principal Investigator: William Roth, M.D.
PRS Account Sensus Healthcare
Verification Date April 2019