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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • -

    Exclusion Criteria:

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06621810
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

German Cancer Research Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Titus J Brinker, PD Dr. med
Principal Investigator Affiliation German Cancer Research Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Germany, Italy, Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Melanoma (Skin Cancer), Artificial Intelligence (AI), Pediatric Cancer
Study Website: View Trial Website

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

University of Tübingen, Tübingen, Germany

Status

Completed

Address

University of Tübingen

Tübingen, , 72074

University of Florence, Florence, Italy

Status

Completed

Address

University of Florence

Florence, , 50121

Hospital Clínic de Barcelona, Barcelona, Spain

Status

Recruiting

Address

Hospital Clínic de Barcelona

Barcelona, , 08036

Site Contact

Susana Puig

[email protected]

+49 15175084347

Stay Informed & Connected