Actively Recruiting

Age: 1Day +
All Genders
ID03001180

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

Age: 1Day +
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

You will not qualify if you...

  • N/A

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Sample Collection

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

Diagnostic Evaluation

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

Long-term Monitoring

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

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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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