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

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ClinicalTrials.gov Identifier: NCT03693937
Recruitment Status : Completed
First Posted : October 3, 2018
Results First Posted : July 4, 2019
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Sensus Healthcare

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Non-melanoma Skin Cancer
Intervention Radiation: SRT-100
Enrollment 776
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Non-Melanoma Skin Cancers (NMSCs)
Hide Arm/Group Description Non-Melanoma Skin Cancers (NMSCs) treated with SRT-100 therapy.
Period Title: Overall Study
Started 776
Completed 776
Not Completed 0
Arm/Group Title Non-Melanoma Skin Cancers (NMSCs)
Hide Arm/Group Description Non-Melanoma Skin Cancers (NMSCs) treated with SRT-100 therapy.
Overall Number of Baseline Participants 516
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 516 participants
78.94  (8.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 516 participants
Female
223
  43.2%
Male
293
  56.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Participant Race Number Analyzed 516 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
516
 100.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 516 participants
516
 100.0%
1.Primary Outcome
Title Cure Rate
Hide Description NMSC cure rate will be calculated as the percentage of lesions that attained complete cure following SRT-100 treatment completion.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Melanoma Skin Cancers (NMSCs)
Hide Arm/Group Description:
Non-Melanoma Skin Cancers (NMSCs) treated with SRT-100 therapy.
Overall Number of Participants Analyzed 776
Overall Number of Units Analyzed
Type of Units Analyzed: Lesions
760
Measure Type: Number
Unit of Measure: lesions
751
Time Frame 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Non-Melanoma Skin Cancers (NMSCs)
Hide Arm/Group Description Non-Melanoma Skin Cancers (NMSCs) treated with SRT-100 therapy.
All-Cause Mortality
Non-Melanoma Skin Cancers (NMSCs)
Affected / at Risk (%)
Total   0/776 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Non-Melanoma Skin Cancers (NMSCs)
Affected / at Risk (%)
Total   0/776 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Non-Melanoma Skin Cancers (NMSCs)
Affected / at Risk (%)
Total   6/776 (0.77%) 
Skin and subcutaneous tissue disorders   
Radiation Dermatitis   6/776 (0.77%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Isabelle Raymond
Organization: Sensus Healthcare
Phone: 561-922-5808
EMail: iraymond@sensushealthcare.com
Layout table for additonal information
Responsible Party: Sensus Healthcare
ClinicalTrials.gov Identifier: NCT03693937     History of Changes
Other Study ID Numbers: SRTS-SRT-001
First Submitted: October 1, 2018
First Posted: October 3, 2018
Results First Submitted: April 16, 2019
Results First Posted: July 4, 2019
Last Update Posted: July 4, 2019