Poor correlation between spectrophotometric intracutaneous analysis and histopathology in melanoma and non-melanoma lesions
| ISRCTN | ISRCTN81210311 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81210311 |
| Secondary identifying numbers | VGSKAS-11928, VGFOUSKB-8498, VGFOUSKB-7934, VGFOUREG-8263 |
- Submission date
- 27/01/2010
- Registration date
- 18/02/2010
- Last edited
- 28/08/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Karin Terstappen
Scientific
Scientific
Skaraborg Hospital
Dept of Dermatology
Skövde
541 85
Sweden
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| Scientific title | Comparison of diagnostic information from spectrophotometric intracutaneous analysis and histopathology in melanoma and non-melanoma lesions: an observational study |
| Study objectives | 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(s) | Regional Ethics Committee of Gothenburg (Regionala etikprövningsnämnden i Göteborg) approved on the 23/02/2004 (ref: 018-04) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2004 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | Lesions clinically suspicious for melanoma and showing positive SIAscopic findings during routine investigations |
| Key exclusion criteria | Aged under 18 years |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 31/12/2007 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Skaraborg Hospital
Skövde
541 85
Sweden
541 85
Sweden
Sponsor information
Research and Development council, Västra Götaland (Forskning och Utveckling, Västra Götaland [Fou VGreg]) (Sweden)
University/education
University/education
Hälso- och sjukvårdsavd Regionkansliet
Regionens Hus
Göteborg
405 44
Sweden
| Website | http://www.fou.nu/is/vgregion |
|---|---|
"ROR" |
https://ror.org/00a4x6777 |
Funders
Funder type
Research organisation
Research and Development council, Västra Götaland (Forskning och Utveckling, Västra Götaland [Fou VGreg]) (Sweden) (ref: VGFOUSKB-8498, VGFOUSKB-7934)
No information available
Research and Development council, Skaraborg (Forskning och Utveckling, Skaraborg [FoU Skaraborg]) (Sweden)
No information available
Research and Development council, Skaraborgs Sjukhus (Forskning och Utveckling, Skaraborgs Sjukhus [FoU SkaS]) (Sweden) (ref: VGSKAS-11928)
No information available
Skaraborg institute (Sweden)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2013 | Yes | No |
