N/A
N=183
Survey Study - Sensitivity Comparison Between MelaFind and Physician Group
Melanoma
Bottom Line
View on ClinicalTrials.gov: NCT01011153 ↗Enrolled (actual)
183
Serious AEs
—
Results posted
Jan 2011
Primary outcome: Primary: Comparison of Biopsy/Referral Sensitivity of MelaFind and Dermatologists (Pigmented Skin Lesion Experts and General Dermatologists) — 0.72; 0.97; 0.51; 0.09 Proportion of True Cases — p=<0.0001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- MELA Sciences, Inc.
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Biopsy/Referral Sensitivity of MelaFind and Dermatologists (Pigmented Skin Lesion Experts and General Dermatologists) |
0.72; 0.97; 0.51; 0.09 | <0.0001 sig |
| SECONDARY 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 |
0.73; 0.71; 0.71; 0.97; 0.51; 0.50 | <0.0001 sig |
| SECONDARY Determine the Interobserver Variability in Each of the Above Metrics Within Each of the Caregiver Groups. |
5927; 8263; 5844; 20034 | — |
| SECONDARY 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. |
0.65; 0.63; 0.59; 0.68; 0.66; 0.61 | — |
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. Out of these 183, 155 were accounted for in the data analysis after exclusions were removed from the pool of subjects.
Eligibility Criteria
Inclusion Criteria
- Board Certified physicians or equivalent
Exclusion Criteria
- Did not participate in EOS Protocols 20061 or 20081
Data sourced from ClinicalTrials.gov (NCT01011153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.