Melanoma Accuracy Study; Phase 2

Melanoma Accuracy Study, Phase Two

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.

Study Overview

• Status: Terminated
• Conditions: Melanoma
• Intervention / Treatment: Diagnostic test: active

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.

• Study Type: Observational
• Enrollment (Actual): 121

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3A 4A7
      • Nova Scotia Health
    • Halifax, Nova Scotia, Canada, B3H 4A7
      • Nova Scotia Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 Control group; Patients randomized into this group will follow normal standard of care in Nova Scotia
Group 2 Active group; Patients randomized into this group will be part of the active arm of the study. They will be pre-screened and asked the following questions: Sign an Information and Authorization form; Demographic data: gender, date of birth, ethnicity; Health history (duration of lesion, changes in lesion, specific changes, who identified the lesion, measurement in two greatest dimensions radially and color.	Diagnostic test: active; Pre-screening for melanoma by qualified nurse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-screening lesions low to moderate risk for melanoma by a nurse, will facilitate a more timely diagnosis of melanoma.	Pre-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.	3 years

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Investigators: Principal Investigator: Richard G Lngley, PhD, Nova Scotia Health Authority

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2018
• Primary Completion (Actual): October 10, 2018
• Study Completion (Actual): October 10, 2018

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 14, 2018

Study Record Updates

• Last Update Posted (Actual): November 23, 2022
• Last Update Submitted That Met QC Criteria: November 18, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: 1023029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No