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

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.

8.2 General Inclusion Criteria * Age ≥ 18 years. * Capacity to provide valid informed consent. * Availability to attend a baseline medical evaluation. * Acceptance of the clinical and analytical use of collected information, under confidentiality and data protection regulations (Law 1581/2012). * Meeting at least one specific criterion of the assigned subgroup. 8.3 Exclusion Criteria * Active acute illness (infectious, inflammatory, or chronic disease exacerbation) within the past 4 weeks. * Patients undergoing intensive active oncological treatment (chemotherapy, ongoing radiotherapy) at the time of recruitment. * Severe decompensation of autoimmune, respiratory, or metabolic disease. * Serious uncontrolled systemic disease limiting participation (advanced organ failure, terminal-stage neoplasm). * Confirmed or suspected pregnancy. * Severe cognitive or psychiatric disorder without a responsible caregiver for consent and follow-up. * Insufficient clinical information or inability to complete minimum protocol measurements. * Simultaneous participation in another clinical study that could interfere with result interpretation. * Refusal to participate or absence of informed consent.