"ADEN Platform: Pilot Clinical Validation for Chronic Disease Risk Stratification in Colombia" | NCT07727915

NCT07727915

Overview

NCT ID: NCT07727915
Lead Sponsor: Unidad de Investigación Genética MolecularNETWORK
Official Title: Pilot Clinical Validation of the ADEN Platform for Stratification and Early Detection of Cardiometabolic, Respiratory, Oncological, Autoimmune, and Fragilty Risk in the Colombian Population
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.

Status and Timeline

Status: Enrolling by invitation
Last Update Posted: Jul 27, 2026Actual
Start Date: Aug 1, 2026Estimated
Primary Completion Date: Oct 30, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility 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.

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 120Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: No data available
Locations: UNIGEM

Similar Studies

Participant Group/Arms

Preventive 30 (25%) Baseline comparison; lowest complexity profile

Patients without known chronic disease, interested in anticipatory risk assessment or presenting with initial factors of biological or familial susceptibility.

Diagnostic Test: Molecular Target

Cardiometabolic 40 (33%) Highest prevalence in Colombia; greater statistical power per subgroup

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

Respiratory / Oncological / Autoimmune 30 (25%) Three clinical components; minimum n = 10 per subtyp

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

Older Adult / Frailty 20 (17%) High-complexity profile; enrichment to capture functional heterogenei

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