An observational study in Preventive Cardiology, Respiration Disorders and Oncologic Disease, sponsored by Unidad de Investigación Genética Molecular. Enrolling by invitation at 1 site in Colombia. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Unidad de Investigación Genética Molecular · Observational
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.
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).
4. Hypotheses 4.1 Primary Hypothesis The ADEN platform achieves substantial or almost perfect agreement (weighted Kappa ≥ 0.60) with the reference clinical evaluation in the stratification of cardiometabolic, respiratory, oncological, autoimmune, and frailty risk in the adult Colombian population under real clinical practice conditions.
4.2 Null Hypothesis (H₀) The agreement between ADEN's risk classification and the reference clinical evaluation is less than moderate (weighted Kappa \< 0.40), with no statistically significant difference from chance.
4.3 Secondary Alternative Hypotheses
The ADEN platform is feasible to implement in an intensive 90-day pilot with a retention rate ≥ 80%.
5. Objectives 5.1 General Objective To validate the predictive capacity and operational feasibility of the ADEN platform for early chronic disease risk stratification across four priority clinical profiles in the adult Colombian population.
5.2 Specific Objectives
Identify subclinical findings of preventive relevance not detected by standard clinical practice.
6. Study Design Prospective, longitudinal, observational-analytical pilot study of clinical and operational validation with 90-day follow-up.
Masking: The reference evaluating clinician will not have access to ADEN results at the time of their evaluation (reference evaluator blinding).
7. Sample Size Calculation 7.1 Statistical Rationale The sample size was calculated for the primary objective: estimating the weighted Kappa agreement between ADEN and the reference clinical evaluation with sufficient precision to be clinically interpretable.
7.2 Calculation Parameters
PRIMARY OUTCOME MEASURES
Title: Weighted Cohen's Kappa Coefficient of Agreement Between ADEN Risk Classification and the Blinded Reference Clinical Assessment Description: 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.
Time Frame: Baseline (single paired assessment at enrollment, Study Days 16-50)
513 studies on the registry are indexed under Respiration Disorders; 98 are open to participants now.
This study's planned enrollment of 120 is below the median of 239 across 207 observational studies indexed under Respiration Disorders.
Browse Respiration Disorders studies →Unidad de Investigación Genética Molecular is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
General population that meets the conditions of the different subgroups
8.2 General Inclusion Criteria
Patients without known chronic disease, interested in anticipatory risk assessment or presenting with initial factors of biological or familial susceptibility.
Diagnostic Test: Molecular Target
Patients with at least one of the following: overweight or obesity (BMI ≥ 25 kg/m²), hypertension, dyslipidemia, insulin resistance, prediabetes (fasting blood glucose 100-125 mg/dL or HbA1c 5.7-6.4%), metabolic syndrome (ATP III criteria), or first-degree family history of type 2 diabetes mellitus or cardiovascular disease.
Diagnostic Test: Molecular Target
Individuals in clinically stable condition, without acute decompensation, for whom assessment of early functional patterns, low-grade chronic inflammation, immunological dysfunction, or oncological recurrence/progression risk is relevant. The predominant subcomponent (respiratory, autoimmune, or oncological) will be recorded for differentiated analysis.
Diagnostic Test: Molecular Target
Patients aged 60 years or older, or younger patients meeting frailty criteria (Fried index ≥ 1 criterion), with mild functional impairment, sarcopenia, polypharmacy (≥ 5 medications), or controlled multiple comorbidity.
Diagnostic Test: Molecular Target
dentification of early biomarkers using NGS and Pangenomix
1. Title: Weighted Cohen's Kappa Coefficient of Agreement Between ADEN Risk Classification and the Blinded Reference Clinical Assessment
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.
Time frame: Baseline (single paired assessment at enrollment, Study Days 16-50)
Sensitivity and Specificity of ADEN for Detection of Clinically Significant Risk (%)
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.
Time frame: Baseline (Study Days 16-50)
Percentage of Enrolled Participants Retained Through the 90-Day Pilot (Retention Rate)
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%.
Time frame: Enrollment through Day 90
Number of Participants With at Least One Clinically Actionable Finding Identified by ADEN, Overall and by Clinical Scenario
Clinical utility of the ADEN platform, operationalized as the number and percentage of participants for whom ADEN identified at least one clinically actionable finding - defined as a risk reclassification or a subclinical/incidental finding - that resulted in a documented preventive recommendation or a referral through the study's referral pathway (urgent / priority / scheduled). Results are reported overall and separately for each of the six pre-specified clinical scenarios (preventive, cardiometabolic, respiratory, oncologic, autoimmune, and frailty). Unit of measure: participants.
Time frame: Enrollment through Day 90
Percentage of the Target Sample Enrolled Within the Recruitment Window (Recruitment Completion Rate)
Feasibility of recruitment, measured as the number of participants enrolled divided by the target sample size (N = 120), ×100, within the pre-specified recruitment window.
Time frame: Study Days 16-45
Area Under the Receiver Operating Characteristic Curve (AUC-ROC) for ADEN Risk Classification
Discrimination of the ADEN risk classification, expressed as the area under the ROC curve with 95% CI. The optimal classification threshold is determined by the Youden index.
Time frame: Study Days 16-50
Percentage of Scheduled Study Visits Completed per Participant (Follow-up Adherence)
Number of study visits completed divided by the number of visits scheduled per participant (×100), reported as the mean across participants.
Time frame: Enrollment through Day 90
Mean Change From Baseline to Day 90 in Glycated Hemoglobin (HbA1c)
Within-subject change from baseline to Day 90 in glycated hemoglobin (HbA1c). Analyzed by paired t-test or Wilcoxon signed-rank test, as appropriate. Unit of Measure: percentage of total hemoglobin (%)
Time frame: Baseline and Day 90
Mean Change From Baseline to Day 90 in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Within-subject change from baseline to Day 90 in the HOMA-IR index, a dimensionless measure of insulin resistance. Analyzed by paired t-test or Wilcoxon signed-rank test, as appropriate. Unit of Measure: index score (dimensionless)
Time frame: Baseline and Day 90
Mean Change From Baseline to Day 90 in Systolic and Diastolic Blood Pressure
Within-subject change from baseline to Day 90 in systolic blood pressure and diastolic blood pressure. Analyzed by paired t-test or Wilcoxon signed-rank test, as appropriate. Unit of Measure: mmHg
Time frame: Baseline and Day 90
Mean Change From Baseline to Day 90 in High-Sensitivity C-Reactive Protein (hs-CRP)
Within-subject change from baseline to Day 90 in high-sensitivity C-reactive protein (hs-CRP). Analyzed by paired t-test or Wilcoxon signed-rank test, as appropriate. Unit of Measure: mg/L
Time frame: Baseline and Day 90
Positive Predictive Value (PPV) of ADEN for Clinically Significant Risk
Proportion of ADEN-positive participants who are truly at clinically significant risk, reported with a 95% confidence interval, overall and by subgroup. Unit of Measure: percentage of participants (%)
Time frame: Baseline (Study Days 16-50)
Negative Predictive Value (NPV) of ADEN for Clinically Significant Risk
Proportion of ADEN-negative participants who are truly not at clinically significant risk, reported with a 95% confidence interval, overall and by subgroup. Unit of Measure: percentage of participants (%)
Time frame: Baseline (Study Days 16-50)
Mean Clinician-Perceived Usability Score of the ADEN Platform (System Usability Scale [SUS], range 0-100)
Usability of the ADEN platform as perceived by participating clinicians, measured with the 10-item System Usability Scale (SUS). Total scores range from 0 to 100; higher scores indicate better perceived usability (a score ≥ 68 is conventionally considered above average). Reported as the mean score across clinician assessments.
Time frame: Day 90 (end of the pilot)
Mean Participant Satisfaction Score With the ADEN-Guided Assessment (Client Satisfaction Questionnaire-8 [CSQ-8], range 8-32)
Participant satisfaction with the ADEN-guided assessment, measured with the 8-item Client Satisfaction Questionnaire (CSQ-8). Each item is scored from 1 to 4, yielding a total score from 8 to 32; higher scores indicate greater satisfaction. Reported as the mean total score.
Time frame: Day 90 (end of the pilot)
Plan to share: No
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