Neutrophil Activation Test Using RNA Levels to Assist in the Diagnosis of Abdominal Pain: The NATURAL Study

What this Trial Is About

Researchers are evaluating RNA biomarkers to improve the diagnosis of abdominal pain caused by suspected intra-abdominal infections (IAIs) such as appendicitis, diverticulitis, acute cholecystitis, pancreatitis, peritonitis, pyelonephritis, and abscess. This prospective, observational study aims to validate a panel of six RNA biomarkers found in stabilized whole blood to detect bacterial, biofilm, and viral infections in the abdomen. The study is sponsored by True Bearing Diagnostics, Inc. and conducted at multiple academic medical centers. The main intervention involves collecting blood samples to measure RNA levels using TruNAV, an RNA-based blood test that assesses immune cell activation related to infections. Participants are patients presenting with abdominal pain suspected of an internal infection and scheduled for diagnostic procedures like CT scans, ultrasounds, endoscopy, or surgery. Blood samples are drawn and processed daily for analysis. The study does not alter standard care but records all diagnostic and treatment information. Participants are involved during their emergency department visit where clinical data, lab tests, imaging results, and treatment details are collected. The study compares RNA biomarker results with clinical diagnosis confirmed by imaging or surgery. Follow-up data up to 30 days after the initial visit are reviewed to assess agreement with infection status. No additional long-term follow-up beyond standard care is required. About 1,000 patients aged over 7 years with abdominal pain will be enrolled.

Diagnosis of Abdominal Pain Using RNA Levels: The NATURAL Study