Actively Recruiting

All Genders
Healthy Volunteers
ID06621810

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

Led by German Cancer Research Center · Updated on 2024-10-01

3000

Participants Needed

3

Research Sites

N/A

Total Duration

On this page

Sponsors

G

German Cancer Research Center

Lead Sponsor

U

Universität Tübingen

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are developing supportive artificial intelligence (AI) algorithms to help distinguish melanoma from nevi or other benign pigmented skin lesions, focusing especially on younger patients under 30 years old. The study aims to improve early diagnosis and risk prediction of melanoma, targeting children, adolescents, and young adults. The project is led by the German Cancer Research Center and focuses on vulnerable populations in skin cancer screening. The study involves creating two AI algorithms: one based on dermatoscopic images for skin cancer screening and another based on histological images to assist pathologists when lesions are still suspicious after dermatologic evaluation. The research also includes developing explainability methods to help users understand the AI decisions better, reduce biases, and increase trust in these tools. There is no additional treatment or intervention for participants, as all data come from routine clinical practice. Participants' involvement requires no extra time since the study uses data collected during standard care. Researchers will evaluate the AI models by measuring the Area Under the Receiver Operator Curve (AUROC) and balanced accuracy at the end of the first training and testing cycle (about 1.5 years from the study start), with reevaluations at 6 and 12 months for improvement. This observational study continues until November 2026 and includes healthy volunteers of all ages and genders.

CONDITIONS

Brief Title

Artificial Intelligence Based Melanoma Early Diagnosis and Risk Prediction in Children, Adolescents and Young Adults

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of melanoma or nevus
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Approximately 1.5 years

Participants undergo image analysis and data collection for early diagnosis and risk prediction of melanoma.

Initial assessment followed by reevaluations at 6 and 12 months post-initial assessment

Long-term Monitoring

Duration - Up to 12 months after initial training

Participants are monitored over time to assess and improve model performance for melanoma diagnosis and risk prediction.

Follow-up visits at 6 and 12 months after initial training

Trial Site Locations

Total: 3 locations

1

University of Tübingen

Tübingen, Germany, 72074

Completed

2

University of Florence

Florence, Italy, 50121

Completed

3

Hospital Clínic de Barcelona

Barcelona, Spain, 08036

Actively Recruiting

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Research Team

T

Titus J Brinker, PD Dr. med

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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