Addressing the Musculoskeletal Phenotype in Hypermobile Ehlers-Danlos Syndrome: Biomarker Pilot Study
J
J Thomas Callaghan
Primary Investigator
Enrolling By Invitation
18-100 years
All
Phase
N/A
32 participants needed
2 Locations
Overview
The overall primary objectives are to develop a diagnostic patient phenotype involving biomarkers that does not require a flare as a diagnostic criterion, and to select a MC mediator cluster that reflects the dynamic fluctuations of the disorder
Description
The following are Aims for this protocol: Aim 1: To recruit HEDS/MCA patients and establish their clinical, MS function and biomarker baseline. The statistical goal will be to Identify biomarker or cluster of biomarkers correlates with baseline clinical features; Aim 2: To evaluate biomarker fluctuations with the patients’ syndromic flares to fashion biomarker clusters based on their upward or downward flux, all adjusted for change from baseline; Aim 3: To correlate biomarker clusters derived based on upward or downward flux with clinical dynamic outcomes generated by flares. The ultimate goal is to develop pilot data for an R01 submission that intends to validate the clusters in a large multicenter diagnostic trial that will transition into a targeted intervention trial.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
hEDS-MS/MCA phenotype , Ehlers-Danlos
-
Age: Between 18 Years - 100 Years
-
Gender: All
Inclusion Criteria:
- Patients (male or female) recruited from Dr Francomano’s clinic
- Patients older than 18 years
Exclusion Criteria:
- Known Immunodeficiency Disease or HIV infection or treatment for HIV
- Patients on systemic immunosuppressive agents, other than topical steroids
- Patients with active infection or infections within the past month
- Patients using opiates or dependent on cocaine, amphetamines, opiates, benzodiazepines, or alcohol.
- Patients with life-threatening illnesses
- Patients who have undergone major surgery with in the prior 2 months or who plan to have major surgery within the 4 months after enrollment
- Patients whose condition is attributed to another diagnosis
- Female patients of child-bearing potential, who are known to be pregnant or are trying to become pregnant
Updated on
11 May 2024.
Study ID: 10897, CPHR-IIR-HEDS-MCA-BIOMARKERS
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