Clinical Research Directory

"ADEN Platform: Pilot Clinical Validation for Chronic Disease Risk Stratification in Colombia"

Sponsor: Unidad de Investigación Genética Molecular

Summary

This protocol describes a 90-day prospective pilot study designed to validate the capacity of the ADEN clinical intelligence platform to stratify early chronic disease risk across six priority public health profiles in Colombia. A total of 120 participants will be enrolled across enriched risk groups: preventive/healthy population (n = 30), cardiometabolic (n = 40), respiratory/oncological/autoimmune (n = 30), and older adult/frailty (n = 20). ADEN's performance will be assessed using weighted Kappa agreement against a reference clinical evaluation, with sensitivity, specificity, and 95% confidence intervals as secondary measures. The study is conducted under the principles of the Declaration of Helsinki, CIOMS guidelines, Resolution 8430 of 1993 from the Colombian Ministry of Health, and personal data protection regulations (Law 1581 of 2012). All participants will sign informed consent prior to any procedure.

Official title: Pilot Clinical Validation of the ADEN Platform for Stratification and Early Detection of Cardiometabolic, Respiratory, Oncological, Autoimmune, and Fragilty Risk in the Colombian Population

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