Actively Recruiting
Identification of Biomarkers for Patients with Vascular Anomalies
Led by Children's Hospital Medical Center, Cincinnati · Updated on 2024-11-06
1000
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
L
Lymphangiomatosis and Gorham's Disease Alliance (LGDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying vascular anomalies, which are rare but can be life-threatening and severely impact children and their families. This study aims to identify non-invasive blood biomarkers that can improve diagnosis, monitoring, and treatment of these conditions. Since tissue biopsies can worsen the disease, finding specific blood markers is important to help guide new therapies. The study collects blood samples (serum and plasma) and tissue from participants undergoing surgical removal of vascular anomalies or sclerotherapy. Blood and tissue samples stored in a tissue bank will also be used. Researchers will measure angiogenic factors in blood samples at the start and during therapy. Tissue and blood collected will help identify where biomarkers originate and explore disease pathways for potential new treatments. Participants will have blood drawn during standard care or procedures, with consent. Tissue removed during surgery or blood taken before sclerotherapy will be used for analysis. Researchers will monitor biomarkers every two years to correlate them with diagnosis, disease severity, and response to treatment. The study involves ongoing observation and sample collection to better understand vascular anomalies and improve care.
CONDITIONS
Brief Title
Identification of Biomarkers for Patients with Vascular Anomalies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any patient having labs drawn as standard of care will have blood drawn for the study if consented/assented.
- All patients who are undergoing a surgical procedure or sclerotherapy are currently consented for participation in the tissue bank.
You will not qualify if you...
- N/A
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Ongoing throughout participation
Participants have blood samples collected at baseline and during routine clinical care to measure angiogenic factors and identify biomarkers.
Blood draws occur during standard care lab visits
Duration - As procedures occur
Participants undergoing surgical procedures or sclerotherapy provide tissue or blood samples to assess disease pathways and biomarker sources.
1 to 2 visits depending on surgical or sclerotherapy schedule
Duration - Up to several years
Participants are monitored with biomarker measurements approximately every 2 years to correlate with diagnosis, severity, and therapy response.
Visits approximately every 2 years
Trial Site Locations
Total: 2 locations
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Terminated
2
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
T
Timothy LeCras, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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