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| ID | Type | Description | Link |
|---|---|---|---|
| UPCC-02924 | Other Identifier | University of Pennsylvania Cancer Center (UPCC) | |
| 50526 | Other Identifier | SMART IRB |
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| Name | Class |
|---|---|
| PharPoint Research, Inc. | INDUSTRY |
| Children's Hospital of Philadelphia | OTHER |
| Cooperative Human Tissue Network - Eastern Division (CHTN-ED) | UNKNOWN |
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The purpose of this study is to test the accuracy of using RNA in blood as a way to forecast new fracture healing outcome.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Traumatic Fractures | Anyone age 18 or over presenting to participating sites for care of new, traumatic appendicular fractures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood draws to assess RNA expression levels | Other | None. Standard of Care (SOC) only. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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 |
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Inclusion Criteria:
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.
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:
Index treatment plan:
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.
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Exclusion Criteria
An individual who meets ANY of the following criteria will be excluded from participation in this study:
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All patients who provide blood samples and whose clinically determined fracture outcome is known.
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| Name | Affiliation | Role |
|---|---|---|
| Samir Mehta, MD | University of Pennsylvania | Principal Investigator |
| Annamarie D Horan, MPA, PhD | University of Pennsylvania | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis Medical Center | Sacramento | California | 95817 | United States | ||
| Indiana University |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Osetomics, LLC |
| UNKNOWN |
| Resonant Clinical/Therapak, Claremont, California | UNKNOWN |
| ResearchDx, Irvine, CA | UNKNOWN |
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Venous blood will be collected into PAXgene Blood RNA Tubes which protect and stabilize RNA but not other molecules like DNA.
| Bloomington |
| Indiana |
| 47401-3654 |
| United States |
| University of Missouri | Columbia | Missouri | 65211-0001 | United States |
| Wake Forest University Health Sciences/Advocate Health | Charlotte | North Carolina | 28203 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030-5400 | United States |