Recruiting OBSERVATIONAL NCT07677124

Medical-AI trial: predicting high/low risk and subtype of basal cell carcinoma from dermoscopy images with a CNN — compared with dermatologists (NCT07677124)

Istanbul Training and Research Hospital Updated 2026-06-30

A retrospective observational study evaluating whether a convolutional neural network (CNN) can classify basal cell carcinoma (BCC) as low- or high-risk and predict its histopathological subtype from clinical and dermoscopy images, and compares the model with dermatologists. Histopathology is the reference. Target 2,500; recruiting.

Trial overview (primary data)

  • StatusRecruiting
  • ConditionsBasal Cell Carcinoma
  • SponsorIstanbul Training and Research Hospital
  • Target enrollment2,500 participants
  • Period2026-05-22 〜 2027-05-22

Key points

  • A retrospective observational study of a CNN classifying BCC as low/high-risk and predicting histopathological subtype from dermoscopy and clinical images.
  • Primary objective is low/high-risk classification performance; secondary is subtype prediction and comparison with dermatologists.
  • Cases are histopathologically confirmed BCC from a dermatology archive, with pathology as the ground truth.
  • BCC is the most common skin cancer; identifying a high-risk subtype bears on excision margin and surgical approach.
  • Target 2,500; recruiting. A retrospective performance study, not a replacement for pathology or an establishment of clinical use.
  • Forming a view on high-risk subtype from dermoscopy before biopsy could inform margins and surgical approach.

1Basal cell carcinoma and its subtypes

Basal cell carcinoma (BCC) is the most common type of skin cancer; most grow slowly, but if neglected or incompletely removed they can spread deeply in one area. Planning treatment hinges on distinguishing a higher-grade subtype (high-risk) from a lower one (low-risk). Dermatologists use dermoscopy, a tool that magnifies the skin to see patterns below the surface, but the final subtype is confirmed by pathology of a biopsy.

2Anticipating subtype from clinical and dermoscopic images

This study examines whether that distinction can be supported from images. Per the registry summary, it uses clinical photographs and dermoscopy images with a CNN (a deep-learning method strong at image recognition) to evaluate, as the primary objective, the performance of classifying BCC as low- or high-risk.

Secondarily, it predicts the histopathological subtype and compares the model with the assessments of dermatology physicians. Cases are histopathologically confirmed BCC from a dermatology archive, with pathology as the reference standard. It is retrospective, with a target of 2,500, and it is recruiting.

3Forming a view before the biopsy

Deciding treatment for basal cell carcinoma turns on whether the histological subtype is high risk. The study asks whether that judgement can be supported at the image stage.

Confirmed by biopsy and histologyJudged from dermoscopic images (this study)
The subtype is known with certaintyCould inform planning of margins and surgical approach
The result has to be waited forMaterial for judgement arrives before the test
Serves as the final reference standardPerformance is measured against that standard

Using clinical photographs and dermoscopic images, a convolutional neural network model is evaluated primarily on classifying BCC as low or high risk. Secondary aims cover predicting the histological subtype and comparing against dermatologists' assessments. Comparing against dermatologists matters in positioning AI as support for judgement in the field rather than as a replacement.

Why it matters

Anticipating a high-risk subtype from images before biopsy could aid planning of excision margins and surgical approach. Comparing against dermatologists is a useful way to evaluate imaging AI as an aid (this trial is a retrospective performance study, not an establishment of clinical use).

FAQ

What is dermoscopy?
A tool and technique that magnifies the skin to observe patterns and vessels below the surface, widely used to assess moles and skin cancer. This study uses its images as AI input.
Does the AI replace a biopsy (pathology)?
No. This retrospective study measures CNN performance against pathology as the reference; it does not replace pathology or establish clinical use.

Sources (primary)

Source: ClinicalTrials.gov (U.S. NIH/NLM, public domain). This site does not provide medical advice. Verify the latest and exact details with the official source. This site is not endorsed or certified by the NIH/NLM.

#Medical AI#Clinical trial#CNN#Dermatology#Skin cancer#Imaging
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