Early Detection of Skin Cancer With Sensor Technology
Primary Purpose
Carcinoma, Basal Cell
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
WR-22 model microwave sensor
Sponsored by
About this trial
This is an interventional diagnostic trial for Carcinoma, Basal Cell focused on measuring Detection
Eligibility Criteria
Inclusion Criteria:
- Patient requiring skin biopsy for suspected basal cell carcinoma skin lesion
- 18 years of age or older
Exclusion Criteria:
-Poor english fluency, Pregnancy
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
WR-22 model microwave sensor
Arm Description
Outcomes
Primary Outcome Measures
Positive predictive value
Secondary Outcome Measures
Full Information
NCT ID
NCT02668614
First Posted
January 26, 2016
Last Updated
November 2, 2018
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02668614
Brief Title
Early Detection of Skin Cancer With Sensor Technology
Official Title
Early Detection of Skin Cancer Using Millimetre-Wave Waveguide Reflectometers
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Skin cancer represents a large problem in today's healthcare setting. The majority of cancer diagnoses are attributed to malignant skin diseases including its major types: basal cell carcinoma, squamous cell carcinoma and melanoma. Early diagnoses is critical given early detection of malignant lesions largely increases chances of successful treatment. The current gold standard of diagnosis is histopathological examination of biopsied skin. Biopsies are not only invasive and expensive, they have variable positive predictive value, meaning they may often be preformed unnecessarily. As such, the investigators have developed a skin scanner, which is less bulky and expensive than existing similar technologies, as a tool to evaluate skin lesions prior to determining the need for a biopsy. Their objective is to obtain information in order to validate this skin scanner in the context of its ability to accurately identify basal cell carcinoma skin lesions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Basal Cell
Keywords
Detection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WR-22 model microwave sensor
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
WR-22 model microwave sensor
Primary Outcome Measure Information:
Title
Positive predictive value
Time Frame
Immediately pre-biopsy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient requiring skin biopsy for suspected basal cell carcinoma skin lesion
18 years of age or older
Exclusion Criteria:
-Poor english fluency, Pregnancy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Early Detection of Skin Cancer With Sensor Technology
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