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Not yet recruiting NCT07384949

Correlation of Dermoscopic Findings With Histopathological Features and Invasion Depth in Cutaneous Squamous Cell Carcinoma

Observational Cutaneous Squamous Cell Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cutaneous Squamous Cell Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Correlation of Invasion Depth and Histopathological Features With Dermoscopic Findings in Cutaneous Squamous Cell Carcinoma

Overview

This is a retrospective study including patients diagnosed with cutaneous squamous cell carcinoma between 2016 and 2025. Demographic, clinical, histopathological, and dermoscopic data were obtained from hospital records. Dermoscopic images taken with the FotoFinder dermoscope were independently evaluated by two dermatologists in a blinded manner. In addition, images were labeled using computer software and analyzed to measure the proportion of specific dermoscopic structures within the total lesion area. These quantitative data were used to examine the relationship between dermoscopic features and histopathological findings.

Detailed description

This retrospective study includes patients who were diagnosed with cutaneous squamous cell carcinoma (cSCC) and underwent total excision between 2016 and 2025 at a tertiary dermatology center. Patient data were obtained from the hospital electronic medical record system, including demographic characteristics (age, sex), clinical features (lesion location, size, and morphology), and histopathological parameters such as tumor depth of invasion and histopathological subtype.

Dermoscopic images were acquired using a FotoFinder digital dermoscope as part of routine clinical documentation prior to excision. All dermoscopic images were independently evaluated by two dermatologists who were blinded to the histopathological results. Dermoscopic features, including vascular patterns and keratin-related structures, were recorded according to predefined criteria. Interobserver agreement was assessed, and discordant evaluations were resolved by consensus.

For objective image analysis, dermoscopic images were segmented and annotated using the LabelMe software. Regions of interest corresponding to specific dermoscopic structures were manually labeled, and pixel-based quantitative measurements were extracted using computer-assisted image analysis pipelines developed in the Visual Studio Code environment. The proportional area of each dermoscopic structure relative to the total lesion surface was calculated and recorded as numerical data.

The primary objective of the study is to investigate the relationship between dermoscopic features and histopathological parameters, particularly tumor invasion depth and histopathological subtype. Secondary objectives include assessing whether quantitative dermoscopic measurements can improve the prediction of invasive behavior in cSCC.

Statistical analyses will be performed to evaluate correlations between dermoscopic variables and histopathological outcomes. Appropriate parametric or non-parametric tests will be used depending on data distribution. Multivariate analyses may be conducted to identify independent dermoscopic predictors of deeper tumor invasion. All analyses will be performed using standard statistical software.

As this is a retrospective study using existing clinical data and images, no additional interventions or patient contact are involved. All data will be anonymized prior to analysis in accordance with institutional and ethical regulations.

Primary outcome measures

  • Correlation between dermoscopic features and tumor invasion depth [Time frame: Retrospective analysis of records from 2016 to 2025]

Eligibility criteria

Inclusion Criteria:Age between 18 and 100 years at the time of diagnosis

Histopathologically confirmed cutaneous squamous cell carcinoma

Lesions that underwent total surgical excision

Histopathology reports including both tumor differentiation grade and invasion depth

Availability of dermoscopic images obtained prior to excision

Dermoscopic images of sufficient quality for evaluation and image analysis -

Exclusion criteria

Lesions that received any prior treatment, including radiotherapy, chemotherapy, cryotherapy, or other destructive or topical treatments before excision

Incomplete clinical, dermoscopic, or histopathological data

Poor-quality dermoscopic images not suitable for reliable evaluation or segmentation

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Turkey (Türkiye) · 1 center
  • University of Health Sciences, Istanbul Training and Research Hospital, Department of Derm — Istanbul

Identifiers

NCT: NCT07384949 · ISTEAH-SCC-DERM-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗