MelanomaNCT01011153
Survey Study - Sensitivity Comparison Between MelaFind and Physician Group
An observational study of Melanoma, run by MELA Sciences, Inc..
Trial summary
This survey study purposes to determine and compare the biopsy/referral sensitivity and specificity of MelaFind to the average biopsy/referral sensitivity and specificity of dermatologists. 241 subjects logged into system but only 183 signed consents and completed the intake survey. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Melanoma
- How many people
- 241 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Feb 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Three groups of health care providers who commonly encounter the skin will participate in the study. The population will comprise ninety physicians of which thirty are pigmented skin lesions experts, thirty general dermatologists and thirty primary care physicians.
Who may be able to join
- Board Certified physicians or equivalent
Who cannot join
- Did not participate in EOS Protocols 20061 or 20081
About this study
Official title: Comparison of Diagnostic and Biopsy/Referral Sensitivity to Melanoma Between Three Groups of Physicians and MelaFind
This survey study purposes to determine and compare the biopsy/referral sensitivity and specificity of MelaFind to the average biopsy/referral sensitivity and specificity of dermatologists. 241 subjects logged into system but only 183 signed consents and completed the intake survey. Out of these 183, 155 were accounted for in the data analysis after exclusions were removed from the pool of subjects.
Read the detailed description
Early detection of melanoma is critical for favorable prognosis, since patients with earlier stage melanomas have a much higher probability of survival than with later stages. The traditional method of early detection has been with serial total body skin exams where the health care provider examines all skin surfaces, including mucosa, for suspicious pigmented lesions. Studies have demonstrated that the diagnostic accuracy of physicians for melanoma depends on the level of dermatological training. More important than being able to make a diagnosis of melanoma on clinical impression is the ability to make an appropriate decision to biopsy the lesion. Primary care physicians (PCPs) are often expected to screen for melanoma and only refer to dermatologists when there is a high clinical suspicion of melanoma. However, if PCPs are not adept at diagnosing melanoma, then opportunities for early diagnosis and treatment could be missed. Conversely, the morphology of benign pigmented lesions can often mimic that of early melanomas, resulting in potentially unnecessary dermatology referrals, biopsies, and patient anxiety. Studies have indicated that there is great variability in the ability of PCPs to make a correct decision to biopsy/refer a pigmented lesion (1.5 times greater than dermatologists) as well as for diagnosing melanoma (over 2.5 times greater than dermatologists). To aid in detection of early melanomas, new technologies are being developed.
One such technology is MelaFind, an investigational device that has been developed to give a recommendation for biopsy (or not) of pigmented skin lesions to rule out melanoma. Our hypothesis is that MelaFind will have equal or better sensitivity than pigmented lesion experts in making an appropriate recommendation for biopsy (i.e., MelaFind will be at least as accurate as dermatologists in recommending biopsy for melanomas).
- Conditions
- Melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All Dermatologists | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Biopsy/Referral Sensitivity of MelaFind and Dermatologists (Pigmented Skin Lesion Experts and General Dermatologists)
Sensitivity is the proportion of positive cases (i.e., histologically confirmed melanoma) identified as positive. Specificity is the proportion of negative cases (i.e., histologically confirmed non-melanoma) identified as negative. Because the number of cases given to each dermatologist varied, both sensitivity and specificity were computed for each dermatologist. The primary outcome as stated was to compare the sensitivity and specificity of all dermatologists to that of MelaFind. These metrics, for both the dermatologists and MelaFind, were calculated based on the same 130 lesions.
Measured: April 2010
Secondary outcomes (3)
Comparison of Biopsy/Referral Sensitivity and Specificity of MelaFind to the Average of Biopsy/Referral Sensitivity & Specificity in Each of the Three Groups of Physicians: Pigmented Skin Lesion Experts, General Dermatologists, and Primary Care Physicians
Sensitivity is the proportion of positive cases (i.e., histologically confirmed melanoma) identified as positive. Specificity is the proportion of negative cases (i.e., histologically confirmed non-melanoma) identified as negative. Because the number of cases given to each dermatologist varied, both sensitivity and specificity were computed for each dermatologist. The primary outcome as stated was to compare the sensitivity and specificity of each group of physicians to that of Melafind, which is presented in the statistical analysis.
Measured: December 2009
Determine the Interobserver Variability in Each of the Above Metrics Within Each of the Caregiver Groups.
Each physician was given up to 130 cases and asked whether or not they would biopsy the lesion. Interobserver variability was measured via the kappa statistic indicating how well the physicians' answers to that question agreed within each group. Kappa statistics are reported in the statistical analysis. while numbers rep, they dont reflect the sgreement among the subjects
Measured: December 2009
To Compare Biopsy/Referral Performance and Diagnostic Performance Using Areas Under the Corresponding Receiver Operating Characteristic (ROC) Curves That Illustrate the Trade-offs Between Sensitivity and Specificity Between Three Groups of Physicians.
For each case reviewed, physicians were asked if they thought the lesion was a melanoma (diagnostic sensitivity/specificity) and whether or not they would biopsy or refer the lesion (biopsy/referral sensitivity/specificity. These measurements were compared using areas under the corresponding receiver operating characteristic curves. (see statistical analysis for results) ROC curves (reciver operating curves) are plotted on graphs with an x-axis of sensitivity and a y-axis of 1-specificity.
Measured: June 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- MELA Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suephy Chen, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011153
- Sponsor's protocol ID
- 20063
- Status last verified
- Feb 2012
- First submitted
- 10 Nov 2009
- Last updated
- 14 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Diagnostic and Biopsy/Referral Sensitivity to Melanoma Between Three Groups of Physicians and MelaFind
- ClinicalTrials.gov ID
- NCT01011153
- Acronym / sponsor ID
- 20063
- Conditions
- Melanoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- MELA Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Posted 24 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This survey study purposes to determine and compare the biopsy/referral sensitivity and specificity of MelaFind to the average biopsy/referral sensitivity and specificity of dermatologists. 241 subjects logged into system but only 183 signed consents and completed the intake survey. Out of these 183, 155 were accounted for in the data analysis after exclusions were removed from the pool of subjects.
Detailed description
Early detection of melanoma is critical for favorable prognosis, since patients with earlier stage melanomas have a much higher probability of survival than with later stages. The traditional method of early detection has been with serial total body skin exams where the health care provider examines all skin surfaces, including mucosa, for suspicious pigmented lesions. Studies have demonstrated that the diagnostic accuracy of physicians for melanoma depends on the level of dermatological training. More important than being able to make a diagnosis of melanoma on clinical impression is the ability to make an appropriate decision to biopsy the lesion. Primary care physicians (PCPs) are often expected to screen for melanoma and only refer to dermatologists when there is a high clinical suspicion of melanoma. However, if PCPs are not adept at diagnosing melanoma, then opportunities for early diagnosis and treatment could be missed. Conversely, the morphology of benign pigmented lesions can often mimic that of early melanomas, resulting in potentially unnecessary dermatology referrals, biopsies, and patient anxiety. Studies have indicated that there is great variability in the ability of PCPs to make a correct decision to biopsy/refer a pigmented lesion (1.5 times greater than dermatologists) as well as for diagnosing melanoma (over 2.5 times greater than dermatologists). To aid in detection of early melanomas, new technologies are being developed.
One such technology is MelaFind, an investigational device that has been developed to give a recommendation for biopsy (or not) of pigmented skin lesions to rule out melanoma. Our hypothesis is that MelaFind will have equal or better sensitivity than pigmented lesion experts in making an appropriate recommendation for biopsy (i.e., MelaFind will be at least as accurate as dermatologists in recommending biopsy for melanomas).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Dermatologists | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Three groups of health care providers who commonly encounter the skin will participate in the study. The population will comprise ninety physicians of which thirty are pigmented skin lesions experts, thirty general dermatologists and thirty primary care physicians.
Key inclusion criteria (1 listed)
- Board Certified physicians or equivalent
Key exclusion criteria (1 listed)
- Did not participate in EOS Protocols 20061 or 20081
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of Biopsy/Referral Sensitivity of MelaFind and Dermatologists (Pigmented Skin Lesion Experts and General Dermatologists)
Time frame: April 2010
Sensitivity is the proportion of positive cases (i.e., histologically confirmed melanoma) identified as positive. Specificity is the proportion of negative cases (i.e., histologically confirmed non-melanoma) identified as negative. Because the number of cases given to each dermatologist varied, both sensitivity and specificity were computed for each dermatologist. The primary outcome as stated was to compare the sensitivity and specificity of all dermatologists to that of MelaFind. These metrics, for both the dermatologists and MelaFind, were calculated based on the same 130 lesions.
3 secondary outcomes
Comparison of Biopsy/Referral Sensitivity and Specificity of MelaFind to the Average of Biopsy/Referral Sensitivity & Specificity in Each of the Three Groups of Physicians: Pigmented Skin Lesion Experts, General Dermatologists, and Primary Care Physicians
Time frame: December 2009
Determine the Interobserver Variability in Each of the Above Metrics Within Each of the Caregiver Groups.
Time frame: December 2009
To Compare Biopsy/Referral Performance and Diagnostic Performance Using Areas Under the Corresponding Receiver Operating Characteristic (ROC) Curves That Illustrate the Trade-offs Between Sensitivity and Specificity Between Three Groups of Physicians.
Time frame: June 2010
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Suephy Chen, MD principal investigator
Emory University
Questions about this trial
What is this clinical trial studying?
An observational study of Melanoma, run by MELA Sciences, Inc..
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 14 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 24 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Comparison of Biopsy/Referral Sensitivity of MelaFind and Dermatologists (Pigmented Skin Lesion Experts and General Dermatologists) (time frame: April 2010). 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 14 Feb 2012; AzTrials last refreshed its copy on 28 Oct 2026.