Precision Medicine for L/GCMN and Melanoma 1

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFundacion Clinic per a la Recerca Biomédica

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Not having a melanoma diagnosis

Not having signed the informed consent

Records prior to the year 2012 (as data might not accurately reflect current practices and treatment outcomes)

Trial population

Review and/or analysis of pre-existing medical records, biological samples and data collected from patients that have been visited at our hospital.

Trial design

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

  • Gradient Boosting Survival Analysis (GBSA),

    Other intervention

    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.

  • Concordance index

    Other intervention

    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.

Treatment groups

6,000 Participants
are divided into 1 treatment group
Group A: Melanoma patients2 interventions

Trial outcomes

Primary outcomes

1

Patient prognosis curves

The main outcome of the study will be to obtain prognosis indicators, mainly survival curves and sentinel lymph node (SLNB) positivity, by training artificial intelligence-based models using tabular clinical data in children, adolescents and young adults (CAYA).

Time frame
24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fundacion Clinic per a la Recerca Biomédica

Lead sponsor

Hospital Clinic of Barcelona

Collaborator