Melanoma Accuracy Study; Phase 2

Melanoma Clinical Trial

Official title:

Melanoma Accuracy Study, Phase Two

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03464604
• Other study ID #: 1023029
• Status: Terminated
• Start date: February 28, 2018
• Est. completion date: October 10, 2018

Study information

• Verified date: November 2022
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 121
• Est. completion date: October 10, 2018
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Diagnostic Test:
• active
Pre-screening for melanoma by qualified nurse

Locations

Country	Name	City	State
Canada	Nova Scotia Health	Halifax	Nova Scotia
Canada	Nova Scotia Health	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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