NCT07579312 Diagnosis of Abdominal Pain Using RNA Levels: The NATURAL Study
| NCT ID | NCT07579312 |
| Status | Recruiting |
| Phase | — |
| Sponsor | True Bearing Diagnostics, Inc. |
| Condition | Intra Abdominal Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2026-04-17 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2026-04-17 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Aamir Ali, M.D.
PRINCIPAL INVESTIGATOR
True Bearing Diagnostics, Inc.
Frequently Asked Questions
Who can join the NCT07579312 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, studying Intra Abdominal Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07579312 currently recruiting?
Yes, NCT07579312 is actively recruiting participants. Contact the research team at mcc@truebearingdiagnostics.com for enrollment information.
Where is the NCT07579312 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT07579312 clinical trial?
NCT07579312 is sponsored by True Bearing Diagnostics, Inc.. The principal investigator is Aamir Ali, M.D. at True Bearing Diagnostics, Inc.. The trial plans to enroll 1,000 participants.