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

NCT ID: NCT06621810

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Melanoma (Skin Cancer) Artificial Intelligence (AI) Pediatric Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

* Patients without a melanoma or nevus diagnosis
* images with insufficient image quality
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universität Tübingen

OTHER

Sponsor Role collaborator

University of Florence

OTHER

Sponsor Role collaborator

Fundacio Clinic Barcelona

OTHER

Sponsor Role collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role collaborator

German Cancer Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Titus J Brinker, PD Dr. med

Role: PRINCIPAL_INVESTIGATOR

German Cancer Research Center

Locations

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University of Tübingen

Tübingen, , Germany

Site Status COMPLETED

University of Florence

Florence, , Italy

Site Status COMPLETED

Hospital Clínic de Barcelona

Barcelona, , Spain

Site Status RECRUITING

Countries

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Germany Italy Spain

Central Contacts

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Titus J Brinker, PD Dr. med

Role: CONTACT

+49 15175084347

Facility Contacts

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Susana Puig

Role: primary

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://melcaya.eu

Homepage of the MELCAYA project

Other Identifiers

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MELCAYA-AI-MEL

Identifier Type: -

Identifier Source: org_study_id

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