Clinical trial · Observational
OCT and Invasion in Cutaneous Skin Lesions
The Value of Optical Coherence Tomography in Discrimination Between the Presence and Absence of Invasion in Clinical Actinic Keratosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Actinic Keratoses | — | UNRESOLVED | — |
| Bowen's Disease | Squamous Cell Carcinoma In Situ | ALIAS | 0.90 |
| Cutaneous Squamous Cell Carcinoma | Skin Squamous Cell Carcinoma | ALIAS | 0.90 |
| Diagnosis | — | UNRESOLVED | — |
| Keratosis, Actinic | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical assessment | Other | — | UNRESOLVED |
| Optical Coherence Tomography | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Non-invasive lesion
- description
- Lesion with histological confirmation of a actinic keratosis or Bowens disease (non-invasive lesions).
- interventionNames
- Diagnostic Test: Optical Coherence Tomography
- Other: Clinical assessment
- label
- Invasive lesion
- description
- Lesion with histological confirmation of a squamous cell carcinoma (invasive lesions).
- interventionNames
- Diagnostic Test: Optical Coherence Tomography
- Other: Clinical assessment
Primary outcomes (2)
- measure
- Sensitivity
- timeFrame
- Through study completion, an average of 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (11)
- BACKGROUNDStratigos AJ, Garbe C, Dessinioti C, Lebbe C, Bataille V, Bastholt L, Dreno B, Fargnoli MC, Forsea AM, Frenard C, Harwood CAlpha, Hauschild A, Hoeller C, Kandolf-Sekulovic L, Kaufmann R, Kelleners-Smeets NW, Malvehy J, Del Marmol V, Middleton MR, Moreno-Ramirez D, Pellecani G, Peris K, Saiag P, van den Beuken-van Everdingen MHJ, Vieira R, Zalaudek I, Eggermont AMM, Grob JJ; European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization for Research and Treatment of Cancer (EORTC). European interdisciplinary guideline on invasive squamous cell carcinoma of the skin: Part 1. epidemiology, diagnostics and prevention. Eur J Cancer. 2020 Mar;128:60-82. doi: 10.1016/j.ejca.2020.01.007. Epub 2020 Feb 26. PMID 32113941
- BACKGROUNDHollestein LM, de Vries E, Nijsten T. Trends of cutaneous squamous cell carcinoma in the Netherlands: increased incidence rates, but stable relative survival and mortality 1989-2008. Eur J Cancer. 2012 Sep;48(13):2046-53. doi: 10.1016/j.ejca.2012.01.003. Epub 2012 Feb 16. PMID 22342554
- BACKGROUNDLomas A, Leonardi-Bee J, Bath-Hextall F. A systematic review of worldwide incidence of nonmelanoma skin cancer. Br J Dermatol. 2012 May;166(5):1069-80. doi: 10.1111/j.1365-2133.2012.10830.x. PMID 22251204
- BACKGROUNDSinx KAE, van Loo E, Tonk EHJ, Kelleners-Smeets NWJ, Winnepenninckx VJL, Nelemans PJ, Mosterd K. Optical Coherence Tomography for Noninvasive Diagnosis and Subtyping of Basal Cell Carcinoma: A Prospective Cohort Study. J Invest Dermatol. 2020 Oct;140(10):1962-1967. doi: 10.1016/j.jid.2020.01.034. Epub 2020 Mar 6. PMID 32147505
- BACKGROUNDMoy RL. Clinical presentation of actinic keratoses and squamous cell carcinoma. J Am Acad Dermatol. 2000 Jan;42(1 Pt 2):8-10. doi: 10.1067/mjd.2000.103343. PMID 10607350
- BACKGROUNDAhmady S, Jansen MHE, Nelemans PJ, Kessels JPHM, Arits AHMM, de Rooij MJM, Essers BAB, Quaedvlieg PJF, Kelleners-Smeets NWJ, Mosterd K. Risk of Invasive Cutaneous Squamous Cell Carcinoma After Different Treatments for Actinic Keratosis: A Secondary Analysis of a Randomized Clinical Trial. JAMA Dermatol. 2022 Jun 1;158(6):634-640. doi: 10.1001/jamadermatol.2022.1034.