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855303-RNA Biomarker Validation

A Multi-Center Observational Study to Validate RNA-Biomarkers as Prognostic of Fracture Healing

NCT06872775•University of Pennsylvania

Summary

The purpose of this study is to test the accuracy of using RNA in blood as a way to forecast new fracture healing outcome.

Detailed Description

This study will follow a registry + biospecimen collection format. Subjects will be enrolled at participating Sites as they present for care for new traumatic appendicular skeletal fractures (0 - ≤7 Days post-injury) and will provide blood specimens for study analysis and future use at up to 4 post-injury windows of treatment (i.e., Window 1, 0 - ≤7 Days; Window 2, 8 - ≤14 days; Window 3, 15 - ≤42 Days; and Window 4, 43 - ≤84 Days post-injury).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•To be eligible to participate in this study, a potential subject must meet ALL of the following criteria:
•1. Provision of informed consent for study participation for self in the English language as indicated by a signed and dated, current, and IRB-approved Informed Consent Form (ICF) from
•1. patients making their own SOC clinical decisions prior to the time of the 1st blood sample collection, or
•2. persons initially unable to make their own SOC clinical decisions, who regain capacity to make clinical care decisions after study blood sample collection during the enrollment window and/or before hospital discharge.
•2. Patient is expected to receive follow-up SOC fracture care at the Site.
•3. Either biological sex at birth (i.e., male or female).
•4. Any self-determined gender or sexual preference.
•5. Any race and/or ethnicity combination.
•6. Age 18 years or older at the time of enrollment; no maximum age.
•7. Body weight estimated to be or measured at ≥110 lbs.
+21 more criteria

Exclusion Criteria

•An individual who meets ANY of the following criteria will be excluded from participation in this study:
•1. Enrolled in another research study that requires any study-specific blood draws from 0 - ≤84 Days post-injury or a study that prohibits co-enrollment of any kind.
•2. Traumatic injuries at presentation are limited to soft tissue injuries and/or axial skeletal fractures.
•3. The presentation appendicular fractures is a result of pathological not traumatic mechanism
•4. Any other circumstances that in the opinion of the PI would either put the successful completion of the study at risk, and/or which makes study participation unduly burdensome to the Subject.

Locations (7)

University of California, Davis Medical Center

Sacramento, California, United States

Indiana University

Bloomington, Indiana, United States

University of Missouri

Columbia, Missouri, United States

Wake Forest University Health Sciences/Advocate Health

Charlotte, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas Health Science Center at Houston

Houston, Texas, United States

Key Dates

Start Date

August 25, 2025

Primary Completion Date

August 24, 2028

Completion Date

August 24, 2028

Last Updated

January 16, 2026

Enrollment

110

ESTIMATED participants

Conditions

Fractures, Bone

Interventions

Blood draws to assess RNA expression levels

OTHER

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RECRUITING

Skeletal Effects of Type 1 Diabetes on Low-Trauma Fracture Risk

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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855303-RNA Biomarker Validation

Inclusion Criteria

Exclusion Criteria

Fish Oil in pREgnancY for Personalized Prevention of Early Childhood Asthma

Skeletal Effects of Type 1 Diabetes on Low-Trauma Fracture Risk

Usability of the ADEPTH Sensor for Bore Depth Measurements in Plate Osteosynthesis Procedures

Virtual Reality During Pediatric Cast Removal

MDR - Biomet Cannulated Screws

Acute Application of Antibiotic Powder in Open Fracture Wounds