Pilot Clinical Validation of the ADEN Platform for Stratification and Early Detection of Cardiometabolic, Respiratory, Oncological, Autoimmune, and Fragilty Risk in the Colombian Population
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- 1. Title: Weighted Cohen's Kappa Coefficient of Agreement Between ADEN Risk Classification and the Blinded Reference Clinical Assessment
Study Overview
Brief 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.
Detailed Description
3.1 Public Health Problem The Colombian healthcare system operates under a predominantly reactive model focused on treating advanced disease. Chronic non-communicable diseases (NCDs) account for approximately 71% of global mortality and generate a disproportionate economic burden on health systems. In Colombia, diabetes, cardiovascular disease, and chronic respiratory diseases are responsible for most disability-adjusted life years (DALYs).
Current scientific evidence establishes that multiple chronic diseases have biological detection windows of 10 to 40 years before clinical manifestation. However, the Colombian health system lacks integrated and validated tools to capitalize on these intervention windows.
3.2 Scientific and Technological Gap Available risk stratification platforms have important methodological limitations: they are primarily validated in high-income populations, do not integrate multiple risk domains within a single patient, and lack prospective validation in Latin American primary care settings.
ADEN proposes to bridge this gap by integrating clinical biomarkers, genomic and metabolomic data, structured clinical history, validated clinical algorithms, and artificial intelligence - all within a single platform oriented toward primary and secondary prevention.
3.3 Need for Clinical Validation Prior to any institutional scaling or public policy decision, it is imperative to demonstrate ADEN's clinical validity, diagnostic utility, and operational feasibility under real-world care conditions. This pilot constitutes the first stage of a phased validation process aligned with international methodological standards for diagnostic technologies (STARD 2015, TRIPOD).
Study Design
- Study Type
- Observational
- Observational Model
- Ecologic Or Community
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Outcomes
Primary Outcomes
1. Title: Weighted Cohen's Kappa Coefficient of Agreement Between ADEN Risk Classification and the Blinded Reference Clinical Assessment
Time Frame: Baseline (single paired assessment at enrollment, Study Days 16-50)
Agreement between the ordinal risk category (e.g., low / moderate / high) assigned by the ADEN platform and the category assigned by a blinded reference clinician, quantified by the quadratically-weighted Cohen's Kappa coefficient (range -1 to +1; higher values indicate greater agreement). Reported overall and by subgroup, with 95% CIs estimated by bootstrap (10,000 resamples). Pre-specified success threshold: κ ≥ 0.60.
Sensitivity and Specificity of ADEN for Detection of Clinically Significant Risk (%)
Time Frame: Baseline (Study Days 16-50)
Sensitivity (percentage of participants classified as at clinically significant risk by the reference assessment who were correctly identified by ADEN) and specificity (percentage of participants not at risk correctly classified by ADEN), derived from 2×2 contingency tables, with 95% CIs (Wilson method), overall and by subgroup.
Percentage of Enrolled Participants Retained Through the 90-Day Pilot (Retention Rate)
Time Frame: Enrollment through Day 90
Feasibility of the intensive 90-day pilot, measured as the number of participants completing the Day-90 final assessment divided by the number enrolled (×100). Pre-specified feasibility threshold: ≥ 80%.
Secondary Outcomes
- Percentage of the Target Sample Enrolled Within the Recruitment Window (Recruitment Completion Rate)(Study Days 16-45)
- Number of Participants With at Least One Clinically Actionable Finding Identified by ADEN, Overall and by Clinical Scenario(Enrollment through Day 90)
- Area Under the Receiver Operating Characteristic Curve (AUC-ROC) for ADEN Risk Classification(Study Days 16-50)
- Percentage of Scheduled Study Visits Completed per Participant (Follow-up Adherence)(Enrollment through Day 90)
- Mean Change From Baseline to Day 90 in Glycated Hemoglobin (HbA1c)(Baseline and Day 90)
- Mean Change From Baseline to Day 90 in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)(Baseline and Day 90)
- Mean Change From Baseline to Day 90 in Systolic and Diastolic Blood Pressure(Baseline and Day 90)
- Mean Change From Baseline to Day 90 in High-Sensitivity C-Reactive Protein (hs-CRP)(Baseline and Day 90)
- Positive Predictive Value (PPV) of ADEN for Clinically Significant Risk(Baseline (Study Days 16-50))
- Negative Predictive Value (NPV) of ADEN for Clinically Significant Risk(Baseline (Study Days 16-50))
Investigators
Beatriz Aristizabal
Scientific Director
Unidad de Investigación Genética Molecular