Clinical trial NCT06014697: OCT and Invasion in Cutaneous Skin Lesions
Official title: The Value of Optical Coherence Tomography in Discrimination Between the Presence and Absence of Invasion in Clinical Actinic Keratosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cutaneous Squamous Cell Carcinoma
Bowen's Disease
Actinic Keratoses
Keratosis, Actinic
Diagnosis
Keywords: Optical coherence tomography
Invasion
Diagnostic device
Non-invasive
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 71
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with a histologically confirmed actinic keratosis, bowens disease or cutaneous squamous cell carcinoma, with a clinical differential diagnosis of actinic keratosis and/or bowens disease and cutaneous squamous cell carcinoma, included in a previous study. All patients retrospectively had a OCT scan.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity
timeFrame: Through study completion, an average of 6 months
measure: Specificity
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Negative predictive value
timeFrame: Through study completion, an average of 6 months
measure: Positive predictive value
timeFrame: Through study completion, an average of 6 months
measure: Area under the curve
timeFrame: Through study completion, an average of 6 months
measure: Sensitivity of OCT features
timeFrame: Through study completion, an average of 6 months
measure: Difference OCT and clinical practice
timeFrame: Through study completion, an average of 6 months
measure: Specificity of OCT features
timeFrame: Through study completion, an average of 6 months
measure: Positive predictive value of OCT features
timeFrame: Through study completion, an average of 6 months
measure: Negative predictive value of OCT features
timeFrame: Through study completion, an average of 6 months
measure: Area under the curve for OCT features
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center+
Study officials:
affiliation: Maastricht University Medical Center
name: K Mosterd, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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