Diagnosis of Abdominal Pain Using RNA Levels: The NATURAL Study

NCT07579312 | Recruiting FDA Device

• 1 other identifier: TBDI-05
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intra Abdominal Infections; Appendicitis Acute; Pyelonephritis; Diverticulitis; Epiploic Appendagitis

Keywords

Intra Abdominal Infections; Biomarkers; Appendicitis; Pyelonephritis; Diverticulitis; Epiploic appendagitis; Gastroenteritis

Outcome Measures

Primary Outcomes (1)

• Agreement to Clinical Adjudication of Infection

  The primary outcome is the agreement (concordance) of the experimental TruNAV blood test with the clinically adjudicated diagnosis of intraabdominal infection, such as appendicitis.

  The clinical assessment of infection includes up to 30 days of relevant data after the initial patient visit.

Study Arms (1)

Abdominal Pain

Patients presenting to a physician with abdominal pain of potential infectious cause

Diagnostic Test: TruNAV, an RNA-based blood test for host immune activation by infections

Interventions

TruNAV, an RNA-based blood test for host immune activation by infections DIAGNOSTIC_TEST

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.

Abdominal Pain

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to a physician at an Emergency Department or Gastroenterology Clinic with a primary complaint of abdominal pain that the physician believes could have an infectious etiology.

You may qualify if:

• 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

You may not qualify if:

• Any situation where delay could be detrimental Hemodynamically unstable (see age-adjusted criteria) Prisoner or other involuntary detainee Inability to provide informed consent/assent

Sponsors & Collaborators

• True Bearing Diagnostics, Inc.: lead

Study Sites (1)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Related Publications (1)

• Meltzer AC, Wargowsky RS, Moran S, Jordan T, Toma I, Jepson T, Shu S, Ma Y, McCaffrey TA. Diagnostic accuracy of novel mRNA blood biomarkers of infection to predict outcomes in emergency department patients with undifferentiated abdominal pain. Sci Rep. 2023 Feb 9;13(1):2297. doi: 10.1038/s41598-023-29385-3.

  PMID: 36759691 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Preserved RNA and DNA

MeSH Terms

Conditions

Intraabdominal Infections; Appendicitis; Pyelonephritis; Diverticulitis; Gastroenteritis

Condition Hierarchy (Ancestors)

Infections; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Nephritis, Interstitial; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pyelitis; Male Urogenital Diseases; Diverticular Diseases

Study Officials

• Aamir Ali, M.D.

  True Bearing Diagnostics, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy McCaffrey, Ph.D.

CONTACT

301-455-2008; mcc@truebearingdiagnostics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: April 17, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

US (1)