OCT and Invasion in Cutaneous Skin Lesions

Trial Title: OCT and Invasion in Cutaneous Skin Lesions

NCT ID: NCT06014697

Condition: Cutaneous Squamous Cell Carcinoma
Bowen's Disease
Actinic Keratoses
Keratosis, Actinic
Diagnosis

Conditions: Official terms:
Keratosis, Actinic
Bowen's Disease
Keratosis

Conditions: Keywords:
Optical coherence tomography
Invasion
Diagnostic device
Non-invasive

Study type: Observational

Overall status: Active, not recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Optical Coherence Tomography
Description: 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)
Arm group label: Invasive lesion
Arm group label: Non-invasive lesion

Other name: OCT

Intervention type: Other
Intervention name: Clinical assessment
Description: 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)
Arm group label: Invasive lesion
Arm group label: Non-invasive lesion

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.

Criteria for eligibility:

Study pop:
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.

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Maastricht University Medical Center+

Address:
City: Maastricht
Country: Netherlands

Start date: March 1, 2023

Completion date: December 2023

Lead sponsor:
Agency: Maastricht University Medical Center
Agency class: Other

Source: Maastricht University Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06014697
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