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Diagnosis of Abdominal Pain Using RNA Levels: The NATURAL Study
Neutrophil Activation Test Using RNA Levels to Assist in the Diagnosis of Abdominal Pain: The NATURAL Study
Who can join
Ages 7 and older · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: Age \> 7 yr old Abdominal pain of likely non-traumatic origin Risk of intra-abdominal infection (see IAI signs) Ability to provide informed consent/assent Potential to order abdominal CT, ultrasound, endoscopy, or surgery for possible IAI Exclusion Criteria: Any situation where delay could be detrimental Hemodynamically unstable (see age-adjusted criteria) Prisoner or other involuntary detainee Inability to provide informed consent/assent
About the study
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.
What is being tested
- TruNAV, an RNA-based blood test for host immune activation by infections (diagnostic test)
Sponsor: True Bearing Diagnostics, Inc. · Participants: 1,000 · Started: Apr 17, 2026
Contact the study team
- Timothy McCaffrey, Ph.D. · Phone: 301-455-2008
Official record on ClinicalTrials.gov — NCT07579312
Locations in the U.S.
| District of Columbia | Children's National Hospital, Washington D.C. |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.