Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
VGSKAS-11928, VGFOUSKB-8498, VGFOUSKB-7934, VGFOUREG-8263
Study information
Scientific title
Comparison of diagnostic information from spectrophotometric intracutaneous analysis and histopathology in melanoma and non-melanoma lesions: an observational study
Acronym
Study hypothesis
The aim of this study was to evaluate the diagnostic information given by the SIAscope (Spectrophotometric Intracutaneous Analysis [SIA]) applied to suspicious malignant melanomas by comparison with histopathological findings.
Ethics approval
Regional Ethics Committee of Gothenburg (Regionala etikprövningsnämnden i Göteborg) approved on the 23/02/2004 (ref: 018-04)
Study design
Observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Melanoma
Intervention
The included lesions were SIAscopically imaged and documented before excision and histopathological preparation. A specially developed preparatory and documentary procedure was undertaken to find the areas of interest in the histological sections thus obtaining accurate topographic comparisons to the SIAgraphs.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. SIAgraphs were evaluated for features indicating melanoma and the following were calculated:
1.1. Sensitivity
1.2. Specificity
1.3. Positive Predictive Value (PPV)
1.4. Negative Predictive Value (NPV)
2. Topographical comparisons between SIAscopy findings and histopathology were made.
Level of agreement was assessed by Kappa statistics.
Secondary outcome measures
N/A
Overall trial start date
01/09/2004
Overall trial end date
31/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Lesions clinically suspicious for melanoma and showing positive SIAscopic findings during routine investigations
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
Aged under 18 years
Recruitment start date
01/09/2004
Recruitment end date
31/12/2007
Locations
Countries of recruitment
Sweden
Trial participating centre
Skaraborg Hospital
Skövde
541 85
Sweden
Sponsor information
Organisation
Research and Development council, Västra Götaland (Forskning och Utveckling, Västra Götaland [Fou VGreg]) (Sweden)
Sponsor details
Hälso- och sjukvårdsavd Regionkansliet
Regionens Hus
Göteborg
405 44
Sweden
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Research and Development council, Västra Götaland (Forskning och Utveckling, Västra Götaland [Fou VGreg]) (Sweden) (ref: VGFOUSKB-8498, VGFOUSKB-7934)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Research and Development council, Skaraborg (Forskning och Utveckling, Skaraborg [FoU Skaraborg]) (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Research and Development council, Skaraborgs Sjukhus (Forskning och Utveckling, Skaraborgs Sjukhus [FoU SkaS]) (Sweden) (ref: VGSKAS-11928)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Skaraborg institute (Sweden)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23296145
Publication citations
-
Results
Terstappen K, Suurküla M, Hallberg H, Ericson MB, Wennberg AM, Poor correlation between spectrophotometric intracutaneous analysis and histopathology in melanoma and nonmelanoma lesions., J Biomed Opt, 2013, 18, 6, 061223, doi: 10.1117/1.JBO.18.6.061223.