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NCT06872775

855303-RNA Biomarker Validation

Enrolling by Invitation
Not specifiedAges 18+Observational
University of Pennsylvania
~110 participants
Updated 2026-01-16 on ClinicalTrials.gov
What's tested:Blood draws to assess RNA expression levels

At a glance

Recruiting sites
0 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of subjects with correct predicted outcome
Measured over 0 - 270 days
+1 more outcome measured

Conditions

Fractures, Bone

Explore related trials

Traumatic Fracture

Where it's being run

7 sites across 7 states
California1
Indiana1
Missouri1
North Carolina1
Pennsylvania1
Tennessee1
Texas1

Study leadership

  • Samir Mehta, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania
  • Annamarie D Horan, MPA, PhD · STUDY_DIRECTOR · University of Pennsylvania

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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.
May not be in a location of the body that was chronically paralyzed pre-trauma or has become permanently paralyzed because of the trauma.
Does not include traumatic amputation above the fracture Site for qualifying fractures 2. Index treatment plan:
May be operative or non-operative.
May include staged treatment with or without the use of external fixators, and/or antibiotic beads, and/or other planned intervention.
Does not include hemi- or total arthroplasty to treat the qualifying fracture.
Does not include amputation above the qualifying fracture. 9. In good general health as evidenced by clinical presentation and/or medical history and without any diagnoses that preclude a life expectancy of at least 2 years after injury. 10. No healed or unhealed fractures within 12 months prior to the event resulting in the qualifying fracture. 11. Blood collection through venipuncture at the volume and frequency per protocol is not contraindicated either through past medical history or current clinical status 12. 45 CFR 46 Subpart B: For females of reproductive potential: not pregnant at the time of study enrollment. 13. CFR 46 Subpart C: Does not meet the CFR definition of Prisoner. 14. Other vulnerable populations:

What this trial measures

  • Proportion of subjects with correct predicted outcome0 - 270 days

    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.

  • Intra-Patient Correlation0 - 270 days

    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.