Early Detection of Skin Cancer With Sensor Technology

• Sponsor: Lawson Health Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT02668614
• Collaborator: (none)
• Enrollment: 60
• Arm: 1
• Actual Duration (Months): 24

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Basal Cell	Device: WR-22 model microwave sensor	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Early Detection of Skin Cancer Using Millimetre-Wave Waveguide Reflectometers
• Actual Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Feb 1, 2018
• Actual Study Completion Date: Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: WR-22 model microwave sensor	Device: WR-22 model microwave sensor

Outcome Measures

Primary Outcome Measures

1. Positive predictive value [Immediately pre-biopsy]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Lawson Health Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lawson Health Research Institute
• ClinicalTrials.gov Identifier: NCT02668614
• Other Study ID Numbers: HSREB 107218
• First Posted: Jan 29, 2016
• Last Update Posted: Nov 6, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lawson Health Research Institute: Detection
• Additional relevant MeSH terms: Skin Neoplasms; Carcinoma, Basal Cell

Study Results

No Results Posted as of Nov 6, 2018