Cutaneous Squamous Cell CancerSCC-DERMNCT07384949
Correlation of Dermoscopic Findings With Histopathological Features and Invasion Depth in Cutaneous Squamous Cell Carcinoma
An observational study of Cutaneous Squamous Cell Cancer, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Cancer
- How many people
- 238 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients aged 18 to 100 years who were diagnosed with cutaneous squamous cell carcinoma and treated with total surgical excision between 2016 and 2025. Only cases with complete clinical, dermoscopic, and histopathological records, including documented tumor differentiation and invasion depth, were included. No additional diagnostic or therapeutic procedures were performed as part of the study.
Who may be able to join
None listed.
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
University of Health Sciences, Istanbul Training and Research Hospital, Department of Dermatology
Istanbul, FATİH, 34098
About this study
Official title: Correlation of Invasion Depth and Histopathological Features With Dermoscopic Findings in Cutaneous Squamous Cell Carcinoma
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.
Read the 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.
- Conditions
- Cutaneous Squamous Cell Cancer
- Keywords
- dermoscopy, Dermoscopic features, Histopathology correlation, Tumor invasion depth, Skin cancer imaging, Computer-assisted image analysis, Squamous cell carcinoma
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between dermoscopic features and tumor invasion depth
The association between predefined dermoscopic features and histopathological tumor invasion depth will be evaluated using quantitative and qualitative dermoscopic assessments.
Measured: Retrospective analysis of records from 2016 to 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Squamous Cell CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Selma Nur Sahin, Istanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384949
- Sponsor's protocol ID
- ISTEAH-SCC-DERM-01
- Acronym
- SCC-DERM
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient confidentiality, institutional data protection policies, and the retrospective nature of the study. All analyses will be reported in aggregate form only.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Invasion Depth and Histopathological Features With Dermoscopic Findings in Cutaneous Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07384949
- Acronym / sponsor ID
- SCC-DERM / ISTEAH-SCC-DERM-01
- Conditions
- Cutaneous Squamous Cell Cancer
- Keywords
- dermoscopy, Dermoscopic features, Histopathology correlation, Tumor invasion depth, Skin cancer imaging, Computer-assisted image analysis, Squamous cell carcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients aged 18 to 100 years who were diagnosed with cutaneous squamous cell carcinoma and treated with total surgical excision between 2016 and 2025. Only cases with complete clinical, dermoscopic, and histopathological records, including documented tumor differentiation and invasion depth, were included. No additional diagnostic or therapeutic procedures were performed as part of the study.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between dermoscopic features and tumor invasion depth
Time frame: Retrospective analysis of records from 2016 to 2025
The association between predefined dermoscopic features and histopathological tumor invasion depth will be evaluated using quantitative and qualitative dermoscopic assessments.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient confidentiality, institutional data protection policies, and the retrospective nature of the study. All analyses will be reported in aggregate form only.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Squamous Cell Cancer, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AYSE ESRA KOKU AKSU, Principal Investigator (905059126069, esraaksu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between dermoscopic features and tumor invasion depth (time frame: Retrospective analysis of records from 2016 to 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.