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

Enrolling by invitation

Conditions studied: Preventive Cardiology, Respiration Disorders, Oncologic Disease, Autoimmune, Fragility, Longevity

In brief

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.

Key facts

Study ID
NCT07727915
Run by
Unidad de Investigación Genética Molecular
People needed
120
Starts
2026-08-01
Expected to finish
2026-11-30
Last updated by the study team
2026-07-27

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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