"ADEN Platform: Pilot Clinical Validation for Chronic Disease Risk Stratification in Colombia" (NCT07727915) | Clinical Trial Compass
By InvitationNot Applicable
"ADEN Platform: Pilot Clinical Validation for Chronic Disease Risk Stratification in Colombia"
Colombia120 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1. Title: Weighted Cohen's Kappa Coefficient of Agreement Between ADEN Risk Classification and the Blinded Reference Clinical Assessment
Timeframe: Baseline (single paired assessment at enrollment, Study Days 16-50)
2
Sensitivity and Specificity of ADEN for Detection of Clinically Significant Risk (%)
Timeframe: Baseline (Study Days 16-50)
3
Percentage of Enrolled Participants Retained Through the 90-Day Pilot (Retention Rate)