By InvitationNot Applicable

855303-RNA Biomarker Validation

United States110 participantsStarted 2025-08-25

Plain-language 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.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.

Proportion of subjects with correct predicted outcome

Timeframe: 0 - 270 days

Intra-Patient Correlation

Timeframe: 0 - 270 days

NCT IDNCT06872775

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-08-24

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. 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.