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SciBase International Melanoma Pivotal Study

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ClinicalTrials.gov Identifier: NCT01077050
Recruitment Status : Completed
First Posted : February 26, 2010
Results First Posted : December 30, 2013
Last Update Posted : December 30, 2013
Sponsor:
Information provided by (Responsible Party):
SciBase AB

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Condition Malignant Melanoma
Intervention Device: SciBase III Electrical Impedance Spectrometer
Enrollment 1951
Recruitment Details

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.

Pre-assignment Details 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.
Arm/Group Title Only One Arm in the Study, Thus Not Applicable.
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 1951
Completed 1942
Not Completed 9
Reason Not Completed
Subjects signed ICF could not be located             1
Screen failure             8
Arm/Group Title Biopsied Skin Lesions
Hide Arm/Group Description Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
Overall Number of Baseline Participants 1942
Hide Baseline Analysis Population Description
All study eligible skin lesion(s) were examined with the investigational device, photographed and removed by an excisional biopsy.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1942 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1499
  77.2%
>=65 years
443
  22.8%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1942 participants
49.8  (16.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1942 participants
Female
1013
  52.2%
Male
929
  47.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1942 participants
United States 458
Europe 1484
1.Primary Outcome
Title SciBase Sensitivity and Specificity
Hide Description

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.

Time Frame Post data lock
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Biopsied Skin Lesions
Arm/Group Title Biopsied Skin Lesions
Hide Arm/Group Description:
Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
Overall Number of Participants Analyzed 1611
Overall Number of Units Analyzed
Type of Units Analyzed: Biopsied Skin Lesions
1943
Mean (95% Confidence Interval)
Unit of Measure: Percentage of total lesions
SciBase Sensitivity to melanoma
96.6
(93.7 to 98.4)
SciBase Specificity to non-melanoma
31.4
(29.2 to 33.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Biopsied Skin Lesions
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments The point estimate of the observed sensitivity that is based on generalized linear mixed model is equal to that calculated in the usual manner.
Method Clopper-Pearson 1-sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Sensitivity to Melanoma
Estimated Value 96.6
Confidence Interval (1-Sided) 95%
94.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Biopsied Skin Lesions
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-Pearson 2-sided
Comments Point estimate of the observed sensitivity for Basal Cell Carcinoma
Method of Estimation Estimation Parameter Sensitivity to Basal Cell Carcinoma
Estimated Value 100
Confidence Interval (2-Sided) 95%
92.6 to 100
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Biopsied Skin Lesions
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-Pearson 2-sided
Comments Point estimate of the observed sensitivity for squamous cell carcinoma
Method of Estimation Estimation Parameter Observed sensitivity for squamous cell c
Estimated Value 93.3
Confidence Interval (2-Sided) 95%
68.1 to 99.8
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Biopsied Skin Lesions
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Note that calculating odds ratio adjusting for subjects having multiple lesions, yields similar result.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 13.0
Confidence Interval (2-Sided) 95%
6.6 to 25.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Sensitivity and Specificity
Hide Description

Secondary 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.

Time Frame Post data lock
Outcome Measure Data Not Reported
Time Frame 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.
Adverse Event Reporting Description 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.
 
Arm/Group Title Biopsied Skin Lesions
Hide Arm/Group Description

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.

All-Cause Mortality
Biopsied Skin Lesions
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Biopsied Skin Lesions
Affected / at Risk (%) # Events
Total   0/1915 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Biopsied Skin Lesions
Affected / at Risk (%) # Events
Total   28/1915 (1.46%)    
Blood and lymphatic system disorders   
Neck and facial swelling after lymph node dissection * [1]  1/1915 (0.05%)  1
Gastrointestinal disorders   
Suffered from diarrhea * [2]  1/1915 (0.05%)  1
General disorders   
Suffered from a cold * [3]  1/1915 (0.05%)  1
Experience nausea * [4]  1/1915 (0.05%)  1
Suture came out prematurely * [5]  1/1915 (0.05%)  1
Experienced sensation of fainting * [6]  1/1915 (0.05%)  1
Experienced mild chest pain *  1/1915 (0.05%)  1
Nervous system disorders   
Experienced a headache/migrane post SciBase measurements and surgical excision. *  4/1915 (0.21%)  4
Skin and subcutaneous tissue disorders   
Experienced bleeding through the bandage after excision. *  2/1915 (0.10%)  2
Lesion started to bleed during examination/measurement *  6/1915 (0.31%)  6
Experience of slight pain from excision * [7]  3/1915 (0.16%)  3
Experience of slight pain/pin pricks from probe * [8]  4/1915 (0.21%)  4
Experience of soreness/itch/tingling at excisional/measurement site *  5/1915 (0.26%)  5
Developed infection following excision *  4/1915 (0.21%)  4
Minimal brusing * [9]  1/1915 (0.05%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Suffered from neck and facial swelling 2 days after lymph node dissection surgery had been performed.
[2]
Suffered from diarrhea for two days after measurements and excision
[3]
Suffered from a cold for 3 days after the excision had been performed.
[4]
Experience nausea for 2 days post measurement and excision
[5]
One suture came out prematurely.
[6]
Became pale and felt faint immediately following the biopsy. The subject felt much better after lying down and was able to leave the clinic under his own power.
[7]
Experienced pain from the wound or excisional site.
[8]
Experienced slight pain / pin pricks from the probe. Resolved once the probe was removed or measurements ended.
[9]
Experienced very minimal bruising appeared on the measurement site approximately 10 minutes after four attempts had been made to obtain a device reading.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Director of Clinical Operations
Organization: SciBase
Phone: +46841062001
Responsible Party: SciBase AB
ClinicalTrials.gov Identifier: NCT01077050     History of Changes
Other Study ID Numbers: SIMPS
First Submitted: February 25, 2010
First Posted: February 26, 2010
Results First Submitted: June 12, 2013
Results First Posted: December 30, 2013
Last Update Posted: December 30, 2013