Diagnosing abdominal pain with a six-RNA blood test
Official title: Neutrophil Activation Test Using RNA Levels to Assist in the Diagnosis of Abdominal Pain: The NATURAL Study
Run by True Bearing Diagnostics, Inc. · NCT07579312 · Data updated 2026-11-12
This study will test whether a blood test that measures six RNA markers can help doctors determine if abdominal pain in people aged 7 and older is caused by infections such as appendicitis, diverticulitis, or pyelonephritis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 7 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | True Bearing Diagnostics, Inc. Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Status | Recruiting |
| Started | April 17, 2026 |
| Main results expected | April 2027 |
| Study ends | September 2027 |
| Registry record updated | May 12, 2026 |
| Trial ID | NCT07579312 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People older than 7 years with non-traumatic abdominal pain who are suspected of having an intra-abdominal infection and for whom CT, ultrasound, endoscopy, or surgery may be considered are ideal candidates.
✕Probably not a fit
Patients who are hemodynamically unstable, unable to provide consent or assent, involuntary detainees (e.g., prisoners), or whose pain is clearly traumatic or noninfectious are unlikely to benefit from this observational diagnostic test.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The NATURAL Study is a prospective, pragmatic observational project sponsored by True Bearing Diagnostics and planned at five or more academic centers, including Children's National Hospital. Investigators will collect stabilized whole-blood samples for the TruNAV six-RNA biomarker panel from patients presenting with suspected intra-abdominal infections while participants receive standard clinical evaluation and imaging. RNA results will be compared to clinical diagnoses, imaging, and operative findings to calculate sensitivity, specificity, and predictive values, with a target of ~90% sensitivity and >90% negative predictive value. The protocol is minimal-risk and involves venipuncture and routine data collection without changing clinical care.
Why it matters
Potential benefit: If successful, the test could quickly rule in or rule out abdominal infections, potentially reducing unnecessary imaging and speeding appropriate treatment.
How similar studies have gone: Host-response RNA panels have shown promise for diagnosing infections in sepsis and respiratory illnesses, but applying a six-RNA panel specifically to intra-abdominal infections is a relatively novel application.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Children's National Hospital
Washington D.C., District of Columbia, United States Recruiting
Study contacts
- Principal investigator: Aamir Ali, M.D. — True Bearing Diagnostics, Inc.
- Study coordinator: Timothy McCaffrey, Ph.D.
- Email: mcc@truebearingdiagnostics.com
- Phone: 301-455-2008
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.