Trial Outcomes & Findings for SciBase International Melanoma Pivotal Study (NCT NCT01077050)
NCT ID: NCT01077050
Last Updated: 2013-12-30
Results Overview
This study has two co-primary objectives, aiming to demonstrate the accuracy of SciBase device: 1. Sensitivity ≥ 0.90 to detect Melanoma 2. Sensitivity - (1-Specificity) \> 0.00 Sensitivity is the proportion of correctly identified cases of Melanoma. Specificity is the proportion of correctly identified cases of non-melanoma.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1951 participants
Primary outcome timeframe
Post data lock
Results posted on
2013-12-30
Participant Flow
Recruitment was conducted at five (5) US investigational sites and at seventeen (17) European investigational sites. Recruitment period 2010-2011. In 2012 the last histological analysis was performed.
Potential study subjects were screened according to the inclusion/exclusion criteria. All study eligible skin lesion(s) were then examined with the investigational device, photographed and removed by an excisional biopsy.
Participant milestones
| Measure |
Only One Arm in the Study, Thus Not Applicable.
|
|---|---|
|
Overall Study
STARTED
|
1951
|
|
Overall Study
COMPLETED
|
1942
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Only One Arm in the Study, Thus Not Applicable.
|
|---|---|
|
Overall Study
Subjects signed ICF could not be located
|
1
|
|
Overall Study
Screen failure
|
8
|
Baseline Characteristics
SciBase International Melanoma Pivotal Study
Baseline characteristics by cohort
| Measure |
Biopsied Skin Lesions
n=1942 Participants
Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1499 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
443 Participants
n=5 Participants
|
|
Age Continuous
|
49.8 years
STANDARD_DEVIATION 16.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1013 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
929 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
458 participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
1484 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post data lockPopulation: Biopsied Skin Lesions
This study has two co-primary objectives, aiming to demonstrate the accuracy of SciBase device: 1. Sensitivity ≥ 0.90 to detect Melanoma 2. Sensitivity - (1-Specificity) \> 0.00 Sensitivity is the proportion of correctly identified cases of Melanoma. Specificity is the proportion of correctly identified cases of non-melanoma.
Outcome measures
| Measure |
Biopsied Skin Lesions
n=1943 Biopsied Skin Lesions
Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
|
|---|---|
|
SciBase Sensitivity and Specificity
SciBase Sensitivity to melanoma
|
96.6 Percentage of total lesions
Interval 93.7 to 98.4
|
|
SciBase Sensitivity and Specificity
SciBase Specificity to non-melanoma
|
31.4 Percentage of total lesions
Interval 29.2 to 33.7
|
SECONDARY outcome
Timeframe: Post data lockSecondary confirmatory objective included two co-secondary endpoints that were defined similarly to the co-primary endpoints, but used the Secondary definition of dichotomous reference diagnosis. Positive Reference Diagnosis: Melanoma, Squamous Cell Carcinoma, Basal Cell Carcinoma, Severe Dysplastic Nevus (High grade dysplasia) Negative Reference Diagnosis: All other skin lesions.
Outcome measures
Outcome data not reported
Adverse Events
Biopsied Skin Lesions
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Biopsied Skin Lesions
n=1915 participants at risk
Any adverse advent that occured on a skin/lesion site for whom there had been any contact between the subject's skin and investigational device (SciBase III).
Note that multiple adverse event occured on some subjects. In total 36 Adverse Events were reported on 28 subjects.
|
|---|---|
|
Nervous system disorders
Experienced a headache/migrane post SciBase measurements and surgical excision.
|
0.21%
4/1915 • Number of events 4 • A post-procedure follow up, either by a telephone or investigational site visit, was to be conducted at 7 (seven) +/- 3 (three) days from the SciBase III evaluation, at which time the subject were to be evaluated for any adverse events.
The Safety analysis population includes all subjects for whom there was any contact with subject's skin and the SciBase III investigational device. Therefore the number of subjects included in the safety analysis deviates from both the total number of enrolled and eligible subjects.
|
|
Skin and subcutaneous tissue disorders
Experienced bleeding through the bandage after excision.
|
0.10%
2/1915 • Number of events 2 • A post-procedure follow up, either by a telephone or investigational site visit, was to be conducted at 7 (seven) +/- 3 (three) days from the SciBase III evaluation, at which time the subject were to be evaluated for any adverse events.
The Safety analysis population includes all subjects for whom there was any contact with subject's skin and the SciBase III investigational device. Therefore the number of subjects included in the safety analysis deviates from both the total number of enrolled and eligible subjects.
|
|
Skin and subcutaneous tissue disorders
Lesion started to bleed during examination/measurement
|
0.31%
6/1915 • Number of events 6 • A post-procedure follow up, either by a telephone or investigational site visit, was to be conducted at 7 (seven) +/- 3 (three) days from the SciBase III evaluation, at which time the subject were to be evaluated for any adverse events.
The Safety analysis population includes all subjects for whom there was any contact with subject's skin and the SciBase III investigational device. Therefore the number of subjects included in the safety analysis deviates from both the total number of enrolled and eligible subjects.
|
|
Skin and subcutaneous tissue disorders
Experience of slight pain from excision
|
0.16%
3/1915 • Number of events 3 • A post-procedure follow up, either by a telephone or investigational site visit, was to be conducted at 7 (seven) +/- 3 (three) days from the SciBase III evaluation, at which time the subject were to be evaluated for any adverse events.
The Safety analysis population includes all subjects for whom there was any contact with subject's skin and the SciBase III investigational device. Therefore the number of subjects included in the safety analysis deviates from both the total number of enrolled and eligible subjects.
|
|
Skin and subcutaneous tissue disorders
Experience of slight pain/pin pricks from probe
|
0.21%
4/1915 • Number of events 4 • A post-procedure follow up, either by a telephone or investigational site visit, was to be conducted at 7 (seven) +/- 3 (three) days from the SciBase III evaluation, at which time the subject were to be evaluated for any adverse events.
The Safety analysis population includes all subjects for whom there was any contact with subject's skin and the SciBase III investigational device. Therefore the number of subjects included in the safety analysis deviates from both the total number of enrolled and eligible subjects.
|
|
Skin and subcutaneous tissue disorders
Experience of soreness/itch/tingling at excisional/measurement site
|
0.26%
5/1915 • Number of events 5 • A post-procedure follow up, either by a telephone or investigational site visit, was to be conducted at 7 (seven) +/- 3 (three) days from the SciBase III evaluation, at which time the subject were to be evaluated for any adverse events.
The Safety analysis population includes all subjects for whom there was any contact with subject's skin and the SciBase III investigational device. Therefore the number of subjects included in the safety analysis deviates from both the total number of enrolled and eligible subjects.
|
|
Skin and subcutaneous tissue disorders
Developed infection following excision
|
0.21%
4/1915 • Number of events 4 • A post-procedure follow up, either by a telephone or investigational site visit, was to be conducted at 7 (seven) +/- 3 (three) days from the SciBase III evaluation, at which time the subject were to be evaluated for any adverse events.
The Safety analysis population includes all subjects for whom there was any contact with subject's skin and the SciBase III investigational device. Therefore the number of subjects included in the safety analysis deviates from both the total number of enrolled and eligible subjects.
|
|
General disorders
Suffered from a cold
|
0.05%
1/1915 • Number of events 1 • A post-procedure follow up, either by a telephone or investigational site visit, was to be conducted at 7 (seven) +/- 3 (three) days from the SciBase III evaluation, at which time the subject were to be evaluated for any adverse events.
The Safety analysis population includes all subjects for whom there was any contact with subject's skin and the SciBase III investigational device. Therefore the number of subjects included in the safety analysis deviates from both the total number of enrolled and eligible subjects.
|
|
Blood and lymphatic system disorders
Neck and facial swelling after lymph node dissection
|
0.05%
1/1915 • Number of events 1 • A post-procedure follow up, either by a telephone or investigational site visit, was to be conducted at 7 (seven) +/- 3 (three) days from the SciBase III evaluation, at which time the subject were to be evaluated for any adverse events.
The Safety analysis population includes all subjects for whom there was any contact with subject's skin and the SciBase III investigational device. Therefore the number of subjects included in the safety analysis deviates from both the total number of enrolled and eligible subjects.
|
|
General disorders
Experience nausea
|
0.05%
1/1915 • Number of events 1 • A post-procedure follow up, either by a telephone or investigational site visit, was to be conducted at 7 (seven) +/- 3 (three) days from the SciBase III evaluation, at which time the subject were to be evaluated for any adverse events.
The Safety analysis population includes all subjects for whom there was any contact with subject's skin and the SciBase III investigational device. Therefore the number of subjects included in the safety analysis deviates from both the total number of enrolled and eligible subjects.
|
|
Gastrointestinal disorders
Suffered from diarrhea
|
0.05%
1/1915 • Number of events 1 • A post-procedure follow up, either by a telephone or investigational site visit, was to be conducted at 7 (seven) +/- 3 (three) days from the SciBase III evaluation, at which time the subject were to be evaluated for any adverse events.
The Safety analysis population includes all subjects for whom there was any contact with subject's skin and the SciBase III investigational device. Therefore the number of subjects included in the safety analysis deviates from both the total number of enrolled and eligible subjects.
|
|
General disorders
Suture came out prematurely
|
0.05%
1/1915 • Number of events 1 • A post-procedure follow up, either by a telephone or investigational site visit, was to be conducted at 7 (seven) +/- 3 (three) days from the SciBase III evaluation, at which time the subject were to be evaluated for any adverse events.
The Safety analysis population includes all subjects for whom there was any contact with subject's skin and the SciBase III investigational device. Therefore the number of subjects included in the safety analysis deviates from both the total number of enrolled and eligible subjects.
|
|
Skin and subcutaneous tissue disorders
Minimal brusing
|
0.05%
1/1915 • Number of events 1 • A post-procedure follow up, either by a telephone or investigational site visit, was to be conducted at 7 (seven) +/- 3 (three) days from the SciBase III evaluation, at which time the subject were to be evaluated for any adverse events.
The Safety analysis population includes all subjects for whom there was any contact with subject's skin and the SciBase III investigational device. Therefore the number of subjects included in the safety analysis deviates from both the total number of enrolled and eligible subjects.
|
|
General disorders
Experienced sensation of fainting
|
0.05%
1/1915 • Number of events 1 • A post-procedure follow up, either by a telephone or investigational site visit, was to be conducted at 7 (seven) +/- 3 (three) days from the SciBase III evaluation, at which time the subject were to be evaluated for any adverse events.
The Safety analysis population includes all subjects for whom there was any contact with subject's skin and the SciBase III investigational device. Therefore the number of subjects included in the safety analysis deviates from both the total number of enrolled and eligible subjects.
|
|
General disorders
Experienced mild chest pain
|
0.05%
1/1915 • Number of events 1 • A post-procedure follow up, either by a telephone or investigational site visit, was to be conducted at 7 (seven) +/- 3 (three) days from the SciBase III evaluation, at which time the subject were to be evaluated for any adverse events.
The Safety analysis population includes all subjects for whom there was any contact with subject's skin and the SciBase III investigational device. Therefore the number of subjects included in the safety analysis deviates from both the total number of enrolled and eligible subjects.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60