Status:
TERMINATED
Melanoma Accuracy Study; Phase 2
Lead Sponsor:
Nova Scotia Health Authority
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate the process, accuracy and patient outcomes of pre-screening dermatology referrals in a clinical setting by a qualified nurse. The long-range goal of the propos...
Detailed Description
The purpose of this study is to evaluate the process, accuracy and patient outcomes of pre-screening dermatology referrals in a clinical setting by a qualified nurse using a dermatoscope, triaging sus...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- New referral from a general practitioner to a dermatologist
- Males and females, over the age of 18 are eligible to participate
- Written informed consent from the patient
- Lesion or mole is new, changing color, growing rapidly or has a change in sensation
- Willing to have the lesion excised if necessary per standard of care
- Ability to complete the imaging procedure and willing to complete a basic history
- Pigmented lesion considered low, moderate or high risk for melanoma by a general practitioner
- Exclusion Criteria
- Lesions which are not amenable
- Participant unable to read, understand or sign consent
- Participant under active care by a dermatologist
- Lesion \<2 mm or \>15mm in diameter
- Lesion located on areas of scars, crusts, psoriasis, eczema or similar skin conditions
- Lesion on hair covered areas (e.g. scalp, beard, mustache) where hair cannot be removed
- Lesions located on genitalia not accessible to equipment
- Lesions located in an area that has previously biopsied or subjected to any kind of surgical or ablative procedure
- Lesion with foreign matter, e.g. tattoo or splinter
- Lesion and/or reference located on acute sunburn
- Skin surface not measurable, e.g. lesion on a stalk
- Skin surface not accessible, e.g. inside ears, ears, under nails
- Skin not intact (measurement area), e.g. bleeding or with clinically noticeable ulceration
- Lesions located within 1cm of the eye
- Lesions light in pigment or thick and nodular
- Participants not willing to have the lesion excised
Exclusion
Key Trial Info
Start Date :
February 28 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 10 2018
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT03464604
Start Date
February 28 2018
End Date
October 10 2018
Last Update
November 23 2022
Active Locations (2)
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1
Nova Scotia Health
Halifax, Nova Scotia, Canada, B3A 4A7
2
Nova Scotia Health
Halifax, Nova Scotia, Canada, B3H 4A7