Clinical trial NCT03464604: Melanoma Accuracy Study; Phase 2
Official title: Melanoma Accuracy Study, Phase Two
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Melanoma
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are 18+ (male or female) referred to the Department of Dermatology at the NSHA for a suspicious pigmented lesion(s).

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 proposed program is to improve referral wait times for patients to see a dermatologist for lesions suspicious for melanoma in comparison to normal standards of care in NS. If effective, this screening program would decrease wait times for those patients with lesions suspicious for melanoma providing earlier diagnosis and expedited treatment, and potentially reducing mortality rates.

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 suspicious lesions vs. benign lesions. The long-range goal of the proposed program is to improve referral wait times for patients to see a dermatologist for lesions suspicious for melanoma in comparison to normal standards of care in NS. If effective, this screening program would decrease wait times for those patients with lesions suspicious for melanoma providing earlier diagnosis and expedited treatment, and potentially reducing mortality rates.

Eligibility criteria: 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

Primary outcomes:
measure: Pre-screening lesions low to moderate risk for melanoma by a nurse, will facilitate a more timely diagnosis of melanoma.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health
state: Nova Scotia
city: Halifax
country: Canada
facility: Nova Scotia Health
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Richard G Lngley, PhD
role: PRINCIPAL_INVESTIGATOR
References: