Trial Outcomes & Findings for Does the Aid of MelaFind Affect Clinical Management Decisions (NCT NCT01387581)
NCT ID: NCT01387581
Last Updated: 2014-11-14
Results Overview
Dermatologist sensitivity is the percent of melanomas that dermatologists selected to biopsy. MelaFind sensitivity is the percent of melanomas that MelaFind called "Positive."
Recruitment status
COMPLETED
Target enrollment
227 participants
Primary outcome timeframe
Within 120 days of Data Lock
Results posted on
2014-11-14
Participant Flow
Dermatologists were selected at random from Germany's public dermatology membership list and were invited to participate by letter. Those interested in participating were asked to register online. Eligible dermatologists were selected to participate on a first-come basis and were divided by random placement into one of two study arms.
Dermatologists interested in participating were asked to register online by responding to an Intake Survey. The survey included questions about dermatology training, medical licensure, board certification, and comfort with and frequency of screening for melanoma. Only board certified dermatologists were permitted to participate in the study.
Participant milestones
| Measure |
Without MelaFind
Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
|
With MelaFind
Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
|
Experts Without MelaFind
PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
|
|---|---|---|---|
|
Overall Study
STARTED
|
108
|
107
|
12
|
|
Overall Study
COMPLETED
|
101
|
101
|
9
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Does the Aid of MelaFind Affect Clinical Management Decisions
Baseline characteristics by cohort
| Measure |
Without MelaFind
n=101 Participants
Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
|
With MelaFind
n=101 Participants
Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
|
Experts Without MelaFind
n=9 Participants
PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
|
Total
n=211 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
31-40 years
|
18 participants
n=5 Participants
|
22 participants
n=7 Participants
|
2 participants
n=5 Participants
|
42 participants
n=4 Participants
|
|
Age, Customized
41-50 years
|
48 participants
n=5 Participants
|
44 participants
n=7 Participants
|
5 participants
n=5 Participants
|
97 participants
n=4 Participants
|
|
Age, Customized
51-60 years
|
29 participants
n=5 Participants
|
30 participants
n=7 Participants
|
2 participants
n=5 Participants
|
61 participants
n=4 Participants
|
|
Age, Customized
> 60 years
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
0 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
101 participants
n=5 Participants
|
101 participants
n=7 Participants
|
9 participants
n=5 Participants
|
211 participants
n=4 Participants
|
|
Dermoscopy use
Never
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Dermoscopy use
Rarely
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Dermoscopy use
< half of pigmented skin lesions
|
4 participants
n=5 Participants
|
16 participants
n=7 Participants
|
3 participants
n=5 Participants
|
23 participants
n=4 Participants
|
|
Dermoscopy use
> half of pigmented skin lesions
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
2 participants
n=5 Participants
|
35 participants
n=4 Participants
|
|
Dermoscopy use
Almost all
|
28 participants
n=5 Participants
|
31 participants
n=7 Participants
|
1 participants
n=5 Participants
|
60 participants
n=4 Participants
|
|
Dermoscopy use
Always
|
52 participants
n=5 Participants
|
38 participants
n=7 Participants
|
3 participants
n=5 Participants
|
93 participants
n=4 Participants
|
|
Years in Practice
< 5 years
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Years in Practice
5 - 10 years
|
8 participants
n=5 Participants
|
17 participants
n=7 Participants
|
1 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Years in Practice
11 - 15 years
|
26 participants
n=5 Participants
|
23 participants
n=7 Participants
|
2 participants
n=5 Participants
|
51 participants
n=4 Participants
|
|
Years in Practice
16 - 20 years
|
27 participants
n=5 Participants
|
25 participants
n=7 Participants
|
4 participants
n=5 Participants
|
56 participants
n=4 Participants
|
|
Years in Practice
> 60 years
|
39 participants
n=5 Participants
|
36 participants
n=7 Participants
|
2 participants
n=5 Participants
|
77 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Within 120 days of Data LockDermatologist sensitivity is the percent of melanomas that dermatologists selected to biopsy. MelaFind sensitivity is the percent of melanomas that MelaFind called "Positive."
Outcome measures
| Measure |
Without MelaFind
n=101 Participants
Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
|
With MelaFind
n=101 Participants
Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
|
Experts Without MelaFind
n=9 Participants
PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
|
|---|---|---|---|
|
Sensitivity
|
69.5 percent of true positives
Interval 64.3 to 76.0
|
78.0 percent of true positives
Interval 73.9 to 83.5
|
71.8 percent of true positives
Interval 66.3 to 77.9
|
PRIMARY outcome
Timeframe: Within 120 days of Data LockDermatologist specificity is the percent of non-melanomas that dermatologists selected not to biopsy. MelaFind specificity is the percent of non-melanomas that MelaFind called "Negative."
Outcome measures
| Measure |
Without MelaFind
n=101 Participants
Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
|
With MelaFind
n=101 Participants
Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
|
Experts Without MelaFind
n=9 Participants
PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
|
|---|---|---|---|
|
Specificity
|
55.9 percent of true negatives
Interval 47.3 to 60.5
|
45.8 percent of true negatives
Interval 38.1 to 50.8
|
54.6 percent of true negatives
Interval 46.3 to 59.7
|
Adverse Events
Without MelaFind
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
With MelaFind
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experts Without MelaFind
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place