Diagnosis of Abdominal Pain Using RNA Levels: The NATURAL Study

Condition(s) studied

Investigational drug(s) / intervention(s)

TruNAV, an RNA-based blood test for host immune activation by infections: TruNAV is a qualitative in vitro Diagnostic Multivariate Index Assay (IVDMIA) using digital PCR to quantitatively measure for the presence of Neutrophil ActiVation markers to assist in the diagnosis of non-acute abdominal infection (e.g., appendicitis, gall bladder cholecystitis, gastroenteritis, diverticulitis, pyelonephritis, epiploic appendagitis, urinary tract infection (UTI), pelvic inflammatory disease) for in-patient and out-patient care settings. TruNAV uses the levels of 6 human RNA biomarkers to read the level and type of activation of circulating immune cells in whole blood. TruNAV reports to the healthcare provider a Bacterial Infection Score, BioFilm Score, and Viral Score, indicating whether each score is below or above threshold levels.

Study summary

The NATURAL Study is a prospective, observational, pragmatic study of RNA biomarkers of infections to aid in the diagnosis of abdominal pain.

Summary of Research Study:

Hypothesis: A genomic-derived panel of 6 RNA biomarkers present in stabilized whole blood will provide diagnostic information about the presence of bacterial, biofilm, and viral infections in the abdomen. We hypothesize that biomarkers will be more than 90% sensitive with a high (\>90%) negative predictive value for IAI.

Research Design: The project design is a prospective, pragmatic, observational study. The NATURAL Study will be sponsored by True Bearing Diagnostics, Inc., and performed at 5 or more academic medical centers. Patients with suspected intra-abdominal infections (IAIs), such as appendicitis, diverticulitis, acute cholecystitis, pancreatitis, peritonitis, pyelonephritis, and abscess are candidates for this study. This is a broad category of patients that are defined by the suspicion of an internal abdominal infection, usually involving some type of advanced imaging analysis, such as CT scan or ultrasound. All participants will be consented for this observational, minimal-risk study prior to venipuncture. Ultimately, The NATURAL Study will determine the positive agreement (\~sensitivity) and negative agreement (\~specificity) of the TruNAV RNA biomarkers in relation to the clinical diagnosis of the presence or absence of an IAI, based on CT scans and/or surgical confirmation, the current standard of care for diagnosis of IAI.

Objective: To validate a novel RNA fingerprint in ED patients with suspected IAIs.

The NATURAL Study is designed to determine the accuracy of novel RNA biomarkers for diagnosis of IAI in patients suspected of having IAI. Subgroup analysis will analyse RNA biomarker for multiple types of actual and suspected IAIs (appendicitis, diverticulitis, acute cholecystitis, pancreatitis, peritonitis, pyelonephritis, and abscess.)

Subjects: Approximately 1,000 ED patients presenting with abdominal pain that are candidates to receive CT or other confirmatory diagnostics will be enrolled.

Eligibility

Primary outcome measure(s)

• Agreement to Clinical Adjudication of Infection — The clinical assessment of infection includes up to 30 days of relevant data after the initial patient visit.
  The primary outcome is the agreement (concordance) of the experimental TruNAV blood test with the clinically adjudicated diagnosis of intraabdominal infection, such as appendicitis.

Trial sites (1)