- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07384949
Correlation of Dermoscopic Findings With Histopathological Features and Invasion Depth in Cutaneous Squamous Cell Carcinoma (SCC-DERM)
Correlation of Invasion Depth and Histopathological Features With Dermoscopic Findings in Cutaneous Squamous Cell Carcinoma
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: AYSE ESRA KOKU AKSU, Principal Investigator
- Phone Number: 905059126069
- Email: esraaksu@gmail.com
Study Contact Backup
- Name: SELMA NUR ŞAHİN, MD
- Phone Number: 905321778725
- Email: selmanur6167@gmail.com
Study Locations
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FATİH
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Istanbul, FATİH, Turkey (Türkiye), 34098
- University of Health Sciences, Istanbul Training and Research Hospital, Department of Dermatology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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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Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cutaneous Squamous Cell Carcinoma Patients
This cohort includes patients diagnosed with cutaneous squamous cell carcinoma between 2016 and 2025 who underwent total excision and had available clinical, dermoscopic, and histopathological data in hospital records.
No additional interventions were performed as part of the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Correlation between dermoscopic features and tumor invasion depth
Time Frame: Retrospective analysis of records from 2016 to 2025
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The association between predefined dermoscopic features and histopathological tumor invasion depth will be evaluated using quantitative and qualitative dermoscopic assessments.
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Retrospective analysis of records from 2016 to 2025
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISTEAH-SCC-DERM-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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