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

NCT07727915 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-07-27

No results posted yet for this study

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.

Conditions

  • Preventive Cardiology
  • Respiration Disorders
  • Oncologic Disease
  • Autoimmune
  • Fragility
  • Longevity

Interventions

DIAGNOSTIC_TEST

Molecular Target

dentification of early biomarkers using NGS and Pangenomix

Sponsors & Collaborators

  • Unidad de Investigación Genética Molecular

    lead NETWORK

Principal Investigators

  • Juan M Anaya, MD,PhD, internista reumatologo · Centro Riproduzione e Andrologia

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2026-10-30
Completion
2026-11-30

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07727915 on ClinicalTrials.gov