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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
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Carcinoma, Basal Cell focused on measuring Detection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 26, 2016
    Last Updated
    November 2, 2018
    Sponsor
    Lawson Health Research Institute
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    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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