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Melanoma Accuracy Study; Phase 2

Melanoma Accuracy Study, Phase Two

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03464604
Enrollment
121
Registered
2018-03-14
Start date
2018-02-28
Completion date
2018-10-10
Last updated
2022-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

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.

Interventions

DIAGNOSTIC_TESTactive

Pre-screening for melanoma by qualified nurse

Sponsors

Nova Scotia Health Authority
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pre-screening lesions low to moderate risk for melanoma by a nurse, will facilitate a more timely diagnosis of melanoma.3 yearsPre-screening referrals to the Department of Dermatology by a qualified nurse for patients with lesions, low to moderate risk for melanoma, would facilitate a more timely diagnosis of melanoma, and appropriate triaging of benign lesions.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026