Condition category
Cancer
Date applied
27/01/2010
Date assigned
18/02/2010
Last edited
28/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Karin Terstappen

ORCID ID

Contact details

Skaraborg Hospital
Dept of Dermatology
Skövde
541 85
Sweden

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 measures

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

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

http://www.fou.nu/is/vgregion

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23296145

Publication citations

  1. 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.

Additional files

Editorial Notes