855303-RNA Biomarker Validation

NCT06872775 | Enrolling By Invitation DMC

• 3 other identifiers: 855303UPCC-0292450526
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Fractures, Bone

Keywords

Traumatic Fracture; Appendicular skeleton; long bone; Normal healing; delayed healing; nonunion or non-union or non union; peripheral blood; prognosis

Outcome Measures

Primary Outcomes (2)

• Proportion of subjects with correct predicted outcome

  The proportion of Subjects who have a correctly prognosed Fracture Healing Outcome (Normal Healing vs. Delayed Healing vs Nonunion) via RNA in peripheral blood when captured during four specific Windows: 1. 0 - ≤7 Days post-injury; and/or 2. 8 - ≤14 days post-injury; and/or 3. 15 - ≤42 Days post-injury; and/or 4. 43 - ≤84 Days post-injury as compared to clinically determined outcomes up to 270 Days post-injury.

  0 - 270 days

• Intra-Patient Correlation

  The intra-patient correlation of RNA-biomarker-driven prognostic calls made by the blinded statistician across windows for those patients who contribute \>1 specimen for RNA-biomarker analysis.

  0 - 270 days

Study Arms (1)

New Traumatic Fractures

Anyone age 18 or over presenting to participating sites for care of new, traumatic appendicular fractures.

Other: Blood draws to assess RNA expression levels

Interventions

Blood draws to assess RNA expression levels OTHER

None. Standard of Care (SOC) only.

New Traumatic Fractures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who provide blood samples and whose clinically determined fracture outcome is known.

You may qualify if:

• To be eligible to participate in this study, a potential subject must meet ALL of the following criteria:
• 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
• patients making their own SOC clinical decisions prior to the time of the 1st blood sample collection, or
• 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.
• Patient is expected to receive follow-up SOC fracture care at the Site.
• Either biological sex at birth (i.e., male or female).
• Any self-determined gender or sexual preference.
• Any race and/or ethnicity combination.
• Age 18 years or older at the time of enrollment; no maximum age.
• Body weight estimated to be or measured at ≥110 lbs.
• Presentation for care within 7 calendar days of injury for at least one new traumatic fracture of any bone in the appendicular skeleton with or without additional fractures of the appendicular or axial skeleton and with or without any other traumatic injuries.
• A qualifying fracture:
• May be open or closed as locally defined per SOC.
• May be displaced or non-displaced per SOC.
• Must result from blunt or penetrating trauma.

You may not qualify if:

• An individual who meets ANY of the following criteria will be excluded from participation in this study:
• 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.
• Traumatic injuries at presentation are limited to soft tissue injuries and/or axial skeletal fractures.
• The presentation appendicular fractures is a result of pathological not traumatic mechanism
• 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.

Sponsors & Collaborators

• Cooperative Human Tissue Network - Eastern Division (CHTN-ED): collaborator
• University of Pennsylvania: lead
• PharPoint Research, Inc.: collaborator
• Children's Hospital of Philadelphia: collaborator
• Osetomics, LLC: collaborator
• Resonant Clinical/Therapak, Claremont, California: collaborator
• ResearchDx, Irvine, CA: collaborator

Study Sites (7)

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

Indiana University

Bloomington, Indiana, 47401-3654, United States

Location

University of Missouri

Columbia, Missouri, 65211-0001, United States

Location

Wake Forest University Health Sciences/Advocate Health

Charlotte, North Carolina, 28203, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030-5400, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood will be collected into PAXgene Blood RNA Tubes which protect and stabilize RNA but not other molecules like DNA.

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Samir Mehta, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Annamarie D Horan, MPA, PhD

  University of Pennsylvania

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 12, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): August 24, 2028
• Study Completion (Estimated): August 24, 2028
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

US (7)