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Clinical Trials/NCT06621810
NCT06621810
Recruiting
Not Applicable

AI-MEL: Image Analysis and Machine Learning for Early Diagnosis and Risk Prediction in Children, Adolescents and Young Adults

German Cancer Research Center3 sites in 3 countries3,000 target enrollmentDecember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Melanoma (Skin Cancer)
Sponsor
German Cancer Research Center
Enrollment
3000
Locations
3
Primary Endpoint
Area Under the Receiver Operator Curve (AUROC)
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The goal of this study is to develop supportive diagnostic artificial intelligence algorithms to distinguish melanoma from nevi or other benign pigmented skin lesions, especially in younger patients (below the age of 30). The main goals it aims to achieve are:

  • development of an algorithm based on dermatoscopic images, targeting skin cancer screening in vulnerable populations
  • development of another algorithm based on histological images, intended to be used by pathologists on lesions that are still suspicious of melanoma after dermatologic assessment
  • implementation of explainability methods to enable the user to better comprehend the systems' decisions, avoid biases and increase trust in these applications

There is no additional time commitment for the study participants for this study, as the data used in this project will be collected in routine clinical practice anyway.

Registry
clinicaltrials.gov
Start Date
December 1, 2022
End Date
November 30, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Patients without a melanoma or nevus diagnosis
  • images with insufficient image quality

Outcomes

Primary Outcomes

Area Under the Receiver Operator Curve (AUROC)

Time Frame: First Assessment: Upon completion of the first training and testing cycle (approx. within 1.5 years from the start of the study). Reevaluations: at 6 and 12 months post-initial training for model improvement.

The AUROC is used to measure and compare the diagnostic accuracy of different classifiers. Thereby, a higher value means better diagnostic performance, with an AUROC of 1 being a perfect score.

Secondary Outcomes

  • Balanced accuracy(First Assessment: Upon completion of the first training and testing cycle (approx. within 1.5 years from the start of the study). Reevaluations: at 6 and 12 months post-initial training for model improvement.)

Study Sites (3)

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