NevusNCT02012751
Nevus Doctor Clinical Decision Support
A study testing Nevus doctor program in people with Nevus and Melanoma, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
The "Nevus doctor" is a dermatoscopy based computer decision support tool to assist general practitioners (GPs) in the classification of pigmented skin lesions (PSLs). The aim of the program "Nevus doctor" is to help GPs increase their diagnostic accuracy, in particular regarding the selection of suspicious PSLs that… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Nevus doctor program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2014to Sep 2016
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pigmented skin lesion
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nevus Doctor Clinical Decision Support Program for Pigmented Skin Lesions and Melanoma
The "Nevus doctor" is a dermatoscopy based computer decision support tool to assist general practitioners (GPs) in the classification of pigmented skin lesions (PSLs). The aim of the program "Nevus doctor" is to help GPs increase their diagnostic accuracy, in particular regarding the selection of suspicious PSLs that need biopsy or referral to specialist health care for further assessment. The aim of this study is to investigate the diagnostic performance of the decision support tool in a primary care setting in Norway. We hypothesize that the diagnostic accuracy of the computer program "Nevus doctor" is better than the performance of the GPs.
Read the detailed description
In the trial GPs examine patients who attend a primary health care center. A given PSL is first assessed clinically by the GP and afterwards photographed. A clinical photograph as well as a dermatoscopic photograph is taken, the latter using a dermatoscope attached to the lens of the camera. The dermatoscopic image is then processed by the computer program. The performance of "Nevus doctor" is compared with the GPs' assessment. A dermatologist reviews all cases based on the clinical and dermatoscopic photographs and this assessment serves as the reference standard.
- Being tested
- Nevus doctor program
- Keywords
- Computer-assisted diagnosis, General practice, Dermatoscopy, Melanoma, Nevus
- Medical subject headings
- Nevus, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nevus doctor programDevice
The Nevus doctor program supplies a diagnostic category of pigmented skin lesions based on dermatoscopy images.
| Study group | Role | What they receive |
|---|---|---|
| Nevus doctor program | Experimental | Use of Nevus doctor program to assess the diagnostic category of pigmented skin lesions Receives: Device: Nevus doctor program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of correct test results
The computer program tests whether the appearance of a skin lesion is suggestive of skin cancer. There are two possible test outcomes: "suspicious" or "not suspicious". The reference standard is the assessment done by a dermatologist. The number (and percentage) of skin lesions correctly classified as "suspicious" or "not suspicious" is reported. Furthermore sensitivity, specificity, positive and negative predictive values are calculated.
Measured: Up to 2 weeks from enrollment
Secondary outcomes (1)
Patterns regarding false test results
All cases with false test results are described in order to identify any pattern that can help to explain the false test result: correlation with specific types of skin lesions, poor image quality, gender and age of the patients.
Measured: Up to 2 weeks from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startOct 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NevusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso, The Research Council of Norway
- Responsible party
- Sponsor
- Investigators
- Thomas R Schopf, Ph.D., Principal investigator, University Hospital North-Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012751
- Sponsor's protocol ID
- 2013/1206
- Status last verified
- Jun 2016
- First submitted
- 4 Dec 2013
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nevus Doctor Clinical Decision Support Program for Pigmented Skin Lesions and Melanoma
- ClinicalTrials.gov ID
- NCT02012751
- Acronym / sponsor ID
- 2013/1206
- Keywords
- Computer-assisted diagnosis, General practice, Dermatoscopy, Melanoma, Nevus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- University of Tromso, The Research Council of Norway
- Study start
- Oct 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 16 Dec 2013 (estimated)
- 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 "Nevus doctor" is a dermatoscopy based computer decision support tool to assist general practitioners (GPs) in the classification of pigmented skin lesions (PSLs). The aim of the program "Nevus doctor" is to help GPs increase their diagnostic accuracy, in particular regarding the selection of suspicious PSLs that need biopsy or referral to specialist health care for further assessment. The aim of this study is to investigate the diagnostic performance of the decision support tool in a primary care setting in Norway. We hypothesize that the diagnostic accuracy of the computer program "Nevus doctor" is better than the performance of the GPs.
Detailed description
In the trial GPs examine patients who attend a primary health care center. A given PSL is first assessed clinically by the GP and afterwards photographed. A clinical photograph as well as a dermatoscopic photograph is taken, the latter using a dermatoscope attached to the lens of the camera. The dermatoscopic image is then processed by the computer program. The performance of "Nevus doctor" is compared with the GPs' assessment. A dermatologist reviews all cases based on the clinical and dermatoscopic photographs and this assessment serves as the reference standard.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nevus doctor program | Experimental | Device: Nevus doctor programUse of Nevus doctor program to assess the diagnostic category of pigmented skin lesions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pigmented skin lesion
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Nevus doctor programThe Nevus doctor program supplies a diagnostic category of pigmented skin lesions based on dermatoscopy images. | Device | Nevus doctor program |
Primary outcome
Number of correct test results
Time frame: Up to 2 weeks from enrollment
The computer program tests whether the appearance of a skin lesion is suggestive of skin cancer. There are two possible test outcomes: "suspicious" or "not suspicious". The reference standard is the assessment done by a dermatologist. The number (and percentage) of skin lesions correctly classified as "suspicious" or "not suspicious" is reported. Furthermore sensitivity, specificity, positive and negative predictive values are calculated.
1 secondary outcome
Patterns regarding false test results
Time frame: Up to 2 weeks from enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
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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.
Thomas R Schopf, Ph.D. principal investigator
University Hospital North-Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nevus doctor program in people with Nevus and Melanoma, run by University Hospital of North Norway at 1 site in Norway.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of correct test results (time frame: Up to 2 weeks from enrollment). 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 28 Oct 2016.