Melanoma Accuracy Study; Phase 2

NCT03464604 | Terminated

• 1 other identifier: 1023029
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 2

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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: 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.

Diagnostic Test: active

Interventions

active DIAGNOSTIC_TEST

Pre-screening for melanoma by qualified nurse

Group 2 Active group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (2)

Nova Scotia Health

Halifax, Nova Scotia, B3A 4A7, Canada

Location

Nova Scotia Health

Halifax, Nova Scotia, B3H 4A7, Canada

Location

MeSH Terms

Conditions

Melanoma

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Richard G Lngley, PhD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 14, 2018
• Study Start: February 28, 2018
• Primary Completion: October 10, 2018
• Study Completion: October 10, 2018
• Last Updated: November 23, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)