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Trial record 63 of 2130 for:    accuracy | Recruiting, Not yet recruiting, Available Studies

Melanoma Accuracy Study; Phase 2

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ClinicalTrials.gov Identifier: NCT03464604
Recruitment Status : Not yet recruiting
First Posted : March 14, 2018
Last Update Posted : March 14, 2018
Sponsor:
Information provided by (Responsible Party):
Richard Langley, Nova Scotia Health Authority

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.

Condition or disease Intervention/treatment
Melanoma 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
Estimated Enrollment : 1200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Melanoma Accuracy Study, Phase Two
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

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:

  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
Pre-screening for melanoma by qualified nurse




Primary Outcome Measures :
  1. Pre-screening lesions low to moderate risk for melanoma by a nurse, will facilitate a more timely diagnosis of melanoma. [ Time Frame: 3 years ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03464604


Contacts
Contact: Richard G Langley, PhD 902-473-7141 richardglangley@gmail.com
Contact: Pamela E Publicover-Brouwer, RN 902-473-7141 pamela.publicover-brouwer@nshealth.ca

Sponsors and Collaborators
Nova Scotia Health Authority
Investigators
Principal Investigator: Richard G Lngley, PhD Nova Scotia Health Authority

Responsible Party: Richard Langley, Principal Investigator, Nova Scotia Health Authority
ClinicalTrials.gov Identifier: NCT03464604     History of Changes
Other Study ID Numbers: 1023029
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: March 14, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas