Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05143476 |
| Other study ID # |
W81XWH-19-1-0796 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 26, 2021 |
| Est. completion date |
September 29, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Major Extremity Trauma Research Consortium |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
To define a serum protein-based diagnostic for the progression and failure of fracture
healing, through the identification of a set of serum proteins that appear at early times of
biological healing and show a specific correlation with later radiological and functional
signs used to define delayed healing and non-union.
Description:
Aim 1 Learning Set: At the earliest time in the study when 10 non-unions have been
identified, we will select 10 control patients matched for comorbidities (including a body
mass index>40, smoking history, and diabetes) from the group that has been enrolled for
comparison to the 10 non-union patients. The proteins showing the most substantial changes in
response to either their initial or end point measurements in both healer and non-healer sets
will be identified. Temporal clustering and biological assessment tools will be used to
identify the biological processes and time frames showing altered serum levels for these
markers. A selection process will then use a set of pair wise iterative processes to identify
both single markers and multiple marker subsets that show the best correlations to both mRUST
and union/nonunion diagnosis prior to the current time that the diagnosis for failed healing
is made.
Aim2 Validation Set: As soon as the next group 10 non-union patients are identified a new
group of 10 healers will be selected and the target group of protein identified in phase one
will be tested for robustness in a second study with this new set of non-healers healers.
Assessments of the robustness will be based on level of detection (LOD) and reproducibility
of LOD and diagnostic performance. A third assessment will be carried out with the total
group of 20 non healers identified in both the first and second phases of the project by
rescreening this group against profiles of a final and novel set of 40 new healers. This new
set of healers will be selected from the total patient sets of profiles that have been
collected across the entire study period and again will be randomly selected and matched for
comorbidities. During each subsequent screen we will refine the marker set further taking
into account both performance features, qualitative factors related to a protein's biological
functions and relationships to the processes of healing, and their correlation to the
clinical parameters that we are using to assess progression of healing (union). The last
stage of assessment provides an independent technical biochemical/immunological validation
for the ten best performing proteins. This assessment will be made using a conventional
Western blot assay across a randomized set of 20 profiles from both healers and non-healers
who had been previously screened using the microarray format. This last assay is a quality
control step for protein identification specification.
