Hospital Clínic de Barcelona (Dermatology service)
Barcelona, Catalonia, 08036, Spain
Location status: Recruiting
NCT Number: NCT06608420
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.
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Observational
Barcelona, Catalonia, 08036, Spain
Location status: Recruiting
Precis-Mel 1 is a unicentric observational study using retrospectively collected data. The proposed procedure is to start using data including demographic and family data, genetic data, medical procedures and cancer treatment, cutaneous biopsy, etc. to build a multidimensional dataset and apply AI algorithms that can produce survival curves and sentinel lymph node (SLNB) positivity in CAYA. The approach to be used is presented in the following sub-sections:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 24 months
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).
Contact information is provided by the study sponsor or research team.
Adrián López Canosa, PhD
CONTACT
Susana Puig Sardà, MD, PhD
CONTACT
Fundacion Clinic per a la Recerca Biomédica
Other
Precision Medicine for L/GCMN and Melanoma 1 (Precis-mel 1)
Acronym: Precis-mel 1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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