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Validation of isothermal amplification for determining the concentration of cell-free DNA (cfDNA)

Validation of isothermal amplification for determining the concentration of cell-free DNA (cfDNA) - EPICARE

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00035865
Enrollment
120
Registered
2025-03-04
Start date
2025-03-04
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Both healthy volunteers and patients with various acute and intensive care medical illnesses are included.

Interventions

Group 1: Patients after liver transplantation cfDNA measurement by qPCR and POCT on day 0 by 2 users and on day 5-7, as well as by cfDNA concentration from whole blood on day 0 and day 5-7 by one pers

Sponsors

Universitätsmedizin Mainz
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Liver transplant - Patients with intracranial hemorrhage - Infection - Sepsis - Septic shock - Patients after cardiogenic cardiac arrest and successful cardiopulmonary resuscitation) - Patients with extracorporeal heart replacement (heart-lung machine, veno-arterial extracorporeal membrane oxygenation) - Tumor disease - Rheumatological disease - Polytrauma

Exclusion criteria

Exclusion criteria: - Pregnant women - Breastfeeding women - Palliative therapy approach or therapy goal limitation

Design outcomes

Primary

MeasureTime frame
Descriptive validation isothermal Amplification method compared to the standard: 1.) Exploratory analysis of objectivity 2.) Exploratory analysis of reliability (test stability) 3.) Hypothesis-generating analysis of validity: precision and accuracy both methods (consistency)

Secondary

MeasureTime frame
Descriptive definition of: 4.) Sensitivity and specificity isothermal amplification measurement method for inflammation (C-reactive protein in patients after polytrauma) and for infection (Procalcitonin in patients with infectious diseases) 5.) Determination of the normal value range of the cfDNA concentration (POCT). Subject group 6.) Clinical study: Descriptive correlation of cfDNA values ??with parameters of the clinical course and risk factors

Countries

Germany

Contacts

Public ContactKatharina Hoeter

Universitätsmedizin Mainz

katharina.hoeter@unimedizin-mainz.de+496131 172267

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026