Melanoma Accuracy Study; Phase 2

NCT ID: NCT03464604

Last Updated: 2022-11-23

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 121 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2018-10-10

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.

Conditions

Melanoma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1 Control group

Patients randomized into this group will follow normal standard of care in Nova Scotia

No interventions assigned to this group

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:

1. Sign an Information and Authorization form

2. Demographic data: gender, date of birth, ethnicity

3. Health history (duration of lesion, changes in lesion, specific changes, who identified the lesion, measurement in two greatest dimensions radially and color.

active

Intervention Type: DIAGNOSTIC_TEST

Pre-screening for melanoma by qualified nurse

Interventions

active

Pre-screening for melanoma by qualified nurse

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard G Lngley, PhD

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health Authority

Locations

Nova Scotia Health

Halifax, Nova Scotia, Canada

Nova Scotia Health

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

1023029

Identifier Type: -

Identifier Source: org_study_id