RecruitingNCT06608420

Precision Medicine for L/GCMN and Melanoma 1

Precision Medicine for L/GCMN and Melanoma 1 (Precis-mel 1)


Sponsor

Fundacion Clinic per a la Recerca Biomédica

Enrollment

6,000 participants

Start Date

Mar 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The primary objective of this study is to create a highly multidimensional and multicentric database for melanoma that encompasses cohorts of children, adolescent and young adults. This database will be used to perform survival analysis and evaluate sentinel lymph node (SLNB) positivity in CAYA. The secondary objectives to be met are the following: * Adaptation and optimization of algorithms: work on optimizing existing precision medicine algorithms, which are currently being used in adult patient care, for their application within pediatric and young adult populations. * Implementation of transfer learning: given the limitations associated with pediatric and young adult data, the investigators intend to utilize transfer learning techniques. The study will employ a sequential waterfall methodology, whereby machine learning models trained on adult patient data will be fine-tuned using the more limited data from younger cohorts. * Integration of expert medical opinion: to integrate physician's scientific domain knowledge into the decision support system. This will be facilitated through the comprehensive examination of existing literature, as well as the evaluation of variable risk contributions within each patient group. * AI-based prognostic models: to develop artificial intelligence-based models for the quantitative prognosis of melanoma across the three age groups: adults, young adults, and children.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is collecting medical data and tissue samples from melanoma patients to better understand how the disease develops and responds to treatment. The focus is on large or giant congenital melanocytic nevi (large dark birthmarks present from birth) and melanoma. Researchers want to build a foundation for more personalized treatments. **You may be eligible if...** - You have a confirmed melanoma diagnosis (any age) - You are willing to participate and sign a consent form **You may NOT be eligible if...** - You have not been diagnosed with melanoma - You have not signed the informed consent - Your medical records are from before 2012 Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interventions

OTHERGradient Boosting Survival Analysis (GBSA),

It is a non-deep learning method that effectively addresses data scarcity issues. GBSA adapts the gradient boosting machine algorithm for survival analysis, particularly accommodating censored data. In survival analysis, patients are represented by a triplet (xi, δi, Ti), where xi is the feature vector, Ti is the time to event, and δi indicates whether the observation is censored. Our goal is to estimate the survival function S(t), representing the probability of a patient surviving beyond time t, and the hazard function λ(t), indicating the instantaneous probability of an event occurring at time t.

OTHERConcordance index

The survival model performance will be evaluated using the concordance index (c-index), a metric particularly suited for survival analysis. The c-index assesses the predictive accuracy of our model by comparing predicted and observed event times. A high c-index indicates that our model effectively predicts the order of patient hazard given its input features.


Locations(1)

Hospital Clínic de Barcelona (Dermatology service)

Barcelona, Catalonia, Spain

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NCT06608420


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