Fractures, Bone855303-RNAValNCT06872775
855303-RNA Biomarker Validation
An observational study of Fractures, Bone, run by University of Pennsylvania at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fractures, Bone
- What is being tested?
- Blood draws to assess RNA expression levels
- How many people
- 110 participants
- Where
- 7 sitesUnited States
- Study dates
- 25 Aug 2025to 24 Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who provide blood samples and whose clinically determined fracture outcome is known.
Who may be able to join
- 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).
Show all 31Show fewer
- 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.
- 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
- 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.
- 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.
- No healed or unhealed fractures within 12 months prior to the event resulting in the qualifying fracture.
- Blood collection through venipuncture at the volume and frequency per protocol is not contraindicated either through past medical history or current clinical status
- 45 CFR 46 Subpart B: For females of reproductive potential: not pregnant at the time of study enrollment.
- CFR 46 Subpart C: Does not meet the CFR definition of Prisoner.
- Other vulnerable populations:
- Not an individual with pre-existing or newly acquired permanently impaired decision-making capacity , and/or
- Not an individual who would be considered an economically or educationally disadvantaged person prior to the qualifying injury as determined by the Site study team per Site standards.
- -
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites
Indiana University
Bloomington, Indiana, 47401-3654
Wake Forest University Health Sciences/Advocate Health
Charlotte, North Carolina, 28203
University of Missouri
Columbia, Missouri, 65211-0001
University of Texas Health Science Center at Houston
Houston, Texas, 77030-5400
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of California, Davis Medical Center
Sacramento, California, 95817
About this study
Official title: A Multi-Center Observational Study to Validate RNA-Biomarkers as Prognostic of Fracture Healing
The purpose of this study is to test the accuracy of using RNA in blood as a way to forecast new fracture healing outcome.
Read the 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).
- Conditions
- Fractures, Bone
- Being tested
- Blood draws to assess RNA expression levels
- Keywords
- Traumatic Fracture, Appendicular skeleton, long bone, Normal healing, delayed healing, nonunion or non-union or non union, peripheral blood, prognosis
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draws to assess RNA expression levelsOther
None. Standard of Care (SOC) only.
| Study group | Role | What they receive |
|---|---|---|
| New Traumatic Fractures | Anyone age 18 or over presenting to participating sites for care of new, traumatic appendicular fractures. Receives: Other: Blood draws to assess RNA expression levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 0 - ≤7 Days post-injury; and/or
- 8 - ≤14 days post-injury; and/or
- 15 - ≤42 Days post-injury; and/or
- 43 - ≤84 Days post-injury as compared to clinically determined outcomes up to 270 Days post-injury.
Measured: 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.
Measured: 0 - 270 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start25 Aug 2025
- Primary completion24 Aug 2028 (estimated)
- Study completion24 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, BoneStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- PharPoint Research, Inc., Children's Hospital of Philadelphia, Cooperative Human Tissue Network - Eastern Division (CHTN-ED), Osetomics, LLC, Resonant Clinical/Therapak, Claremont, California, ResearchDx, Irvine, CA
- Responsible party
- Sponsor
- Investigators
- Samir Mehta, MD, Principal investigator, University of PennsylvaniaAnnamarie D Horan, MPA, PhD, Study director, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872775
- Sponsor's protocol ID
- 855303
- Other IDs
- UPCC-02924, 50526
- Acronym
- 855303-RNAVal
- Status last verified
- Jan 2026
- First submitted
- 3 Mar 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Observational Study to Validate RNA-Biomarkers as Prognostic of Fracture Healing
- ClinicalTrials.gov ID
- NCT06872775
- Acronym / sponsor ID
- 855303-RNAVal / 855303
- Conditions
- Fractures, Bone
- Keywords
- Traumatic Fracture, Appendicular skeleton, long bone, Normal healing, delayed healing, nonunion or non-union or non union, peripheral blood, prognosis
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- PharPoint Research, Inc., Children's Hospital of Philadelphia, Cooperative Human Tissue Network - Eastern Division (CHTN-ED), Osetomics, LLC, Resonant Clinical/Therapak, Claremont, California, ResearchDx, Irvine, CA
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 24 Aug 2028 (estimated)
- Study completion
- 24 Aug 2028 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| New Traumatic Fractures | – | Other: Blood draws to assess RNA expression levelsAnyone age 18 or over presenting to participating sites for care of new, traumatic appendicular fractures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who provide blood samples and whose clinically determined fracture outcome is known.
Key inclusion criteria (31 listed)
- 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
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood draws to assess RNA expression levelsNone. Standard of Care (SOC) only. | Other | New Traumatic Fractures |
Primary outcome
Proportion of subjects with correct predicted outcome
Time frame: 0 - 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 Correlation
Time frame: 0 - 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samir Mehta, MD principal investigator
University of Pennsylvania
Annamarie D Horan, MPA, PhD study director
University of Pennsylvania
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fractures, Bone, run by University of Pennsylvania at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 31 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with correct predicted outcome (time frame: 0 - 270 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.