Diagnosis of Abdominal Pain Using RNA Levels: The NATURAL 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 bac
| Condition(s) | Intra Abdominal Infections, Appendicitis Acute, Pyelonephritis, Diverticulitis, Epiploic Appendagitis |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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, a |
| Who can participate | 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 |
| Ages | 7 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | True Bearing Diagnostics, Inc. |
| Locations | Washington D.C., District of Columbia, United States |
| Start date | 2026-04-17 |
| NCT ID | NCT07579312 |
| Official listing | https://clinicaltrials.gov/study/NCT07579312 |