MelanomaNCT03464604
Melanoma Accuracy Study; Phase 2
An observational study of Melanoma, run by Nova Scotia Health Authority at 2 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma
- What is being tested?
- active
- How many people
- 121 participants
- Where
- 2 sitesCanada
- Study dates
- 28 Feb 2018to 10 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients are 18+ (male or female) referred to the Department of Dermatology at the NSHA for a suspicious pigmented lesion(s).
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Nova Scotia Health
Halifax, Nova Scotia, B3A 4A7
Nova Scotia Health
Halifax, Nova Scotia, B3H 4A7
About this study
Official title: 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.
Read the 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
- Being tested
- active
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activeDiagnostic test
Pre-screening for melanoma by qualified nurse
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: active |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start28 Feb 2018
- Primary completion10 Oct 2018
- Study completion10 Oct 2018
Why it stopped: COVID forced the termination of this study. No impact on participants already enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard G Lngley, PhD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464604
- Sponsor's protocol ID
- 1023029
- Status last verified
- Nov 2022
- First submitted
- 27 Feb 2018
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melanoma Accuracy Study, Phase Two
- ClinicalTrials.gov ID
- NCT03464604
- Acronym / sponsor ID
- 1023029
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID forced the termination of this study. No impact on participants already enrolled.
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 10 Oct 2018 (actual)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 Control group | – | –Patients randomized into this group will follow normal standard of care in Nova Scotia |
| Group 2 Active group | – | Diagnostic Test: activePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are 18+ (male or female) referred to the Department of Dermatology at the NSHA for a suspicious pigmented lesion(s).
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| activePre-screening for melanoma by qualified nurse | Diagnostic test | Group 2 Active group |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: COVID forced the termination of this study. No impact on participants already enrolled.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard G Lngley, PhD principal investigator
Nova Scotia Health Authority
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by Nova Scotia Health Authority at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID forced the termination of this study. No impact on participants already enrolled.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-screening lesions low to moderate risk for melanoma by a nurse, will facilitate a more timely diagnosis of melanoma. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.