Actinic Keratoses, Bowen's Disease, Cutaneous Squamous Cell Carcinoma, Diagnosis, Keratosis, Actinic
Conditions
Keywords
Optical coherence tomography, Invasion, Diagnostic device, Non-invasive
Brief summary
The increasing incidence of actinic keratosis (AK), morbus Bowen (MB) and cutaneous squamous cell carcinoma (cSCC), the patients with often multiple lesions and the disadvantages of invasive diagnostics show the need for an accurate non-invasive diagnostic tool for the determination of invasive growth in AK and MB. Optical coherence tomography (OCT) is a non-invasive scanner creating cross-sectional images of the skin, to a depth of 1-1,5 mm based on light waves. Until now, OCT has been proposed as non-invasive diagnostic tool for basal cell carcinomas. Although the diagnostic value of OCT for detection and sub-typing of basal cell carcinomas has already been demonstrated, it is unclear whether OCT can discriminate between invasive and non-invasive lesions (AK, MB and cSCCs). There are some studies that describe OCT characteristics of AK, MB and cSCCs, however, these characteristics have a lot of overlap (8-13). To date there are no clearly distinctive OCT features to distinguish between AK, MB and cSCCs. This study aims to investigate the value of OCT in discriminating between the presence and absence of invasion in lesions with clinical suspicion for invasion. Two experienced OCT-assessors will evaluate the OCT scans independently. The OCT assessors are blinded to the histological diagnosis of the lesions (invasive or non-invasive), which is used as golden standard. A 5-point Likert scale is used for OCT assessment. 1. Definitely not invasive 2. Probably not invasive 3. Unknown, probably invasive/probably not invasive 4. Probably invasive 5. Definitely invasive In addition to completing the Likert-scale, assessors are asked to describe the presence/absence of predefined OCT characteristics (a.o. hyperkeratosis and the presence of the dermo-epidermal junction) In case of disagreement between the independent assessors, the OCT scan will be re-assessed in a consensus meeting.
Interventions
DIAGNOSTIC_TESTOptical Coherence Tomography
Assessment of the lesion with a non-invasive OCT scan according to a confidence scale (5-point Likert scale: 1 Definitely not invasive, 2 Probably not invasive, 3 Unknown invasive or non-invasive, 4 Probably invasive, 5 Definitely invasive)
OTHERClinical assessment
Clinical assessment of the lesion by a dermatologist according to a confidence scale (5-point Likert scale: 1 Definitely not invasive, 2 Probably not invasive, 3 Unknown invasive or non-invasive, 4 Probably invasive, 5 Definitely invasive)
Sponsors
Maastricht University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who are included in a previous study on OCT, with written informed consent to use their data regarding OCT. * Patients who retrospectively had an OCT scan for their skin lesion * With a histological confirmed actinic keratosis, bowens disease or cutaneous squamous cell carcinoma of the skin * with a differential diagnosis of a invasive lesion (cutaneous squamous cell carcinoma) and a non-invasive lesion (bowens disease or actinic keratosis).
Exclusion criteria
* patients who waived informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | Through study completion, an average of 6 months | Sensitivity of OCT to detect invasion |
| Specificity | Through study completion, an average of 6 months | Specificity of OCT in determining the presence/absence of invasion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve | Through study completion, an average of 6 months | Area under the curve for OCT in determining the presence/absence of invasion |
| Sensitivity of OCT features | Through study completion, an average of 6 months | Sensitivity for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis. |
| Difference OCT and clinical practice | Through study completion, an average of 6 months | Difference in diagnostic parameters (sensitivity, specificity and area under the curve) between OCT and clinical practice (clinical assessment). |
| Negative predictive value | Through study completion, an average of 6 months | Negative predictive value of OCT in determining the presence/absence of invasion |
| Positive predictive value of OCT features | Through study completion, an average of 6 months | Positive predictive value for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis. |
| Negative predictive value of OCT features | Through study completion, an average of 6 months | Negative predictive value for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis. |
| Area under the curve for OCT features | Through study completion, an average of 6 months | Area under the curve for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis. |
| Specificity of OCT features | Through study completion, an average of 6 months | Specificity for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis. |
| Positive predictive value | Through study completion, an average of 6 months | Positive predictive value of OCT in determining the presence/absence of invasion |
Countries
Netherlands
Outcome results
None listed