NCT03001180

Identification of Biomarkers for Patients with Vascular Anomalies

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 1 Day
• Healthy volunteers: Not accepted

Summary

The study will use blood (serum and plasma) and tissue obtained from participants undergoing prescribed surgical resection of vascular anomalies of interest proposed in this study. The study will also use blood (serum and plasma) and tissue collected and stored in a tissue bank maintained by the Department of Hematology/Oncology.

Detailed description

While vascular anomalies are rare diseases, they can be life-threatening and devastating to affected children and their families. Advances in diagnosis, monitoring and therapies will be significantly improved if non-invasive biomarkers that are sensitive and specific can be identified. Obtaining a tissue biopsy to help in diagnosis can actually worsen the disease and so identification of specific blood biomarkers is highly desirable. Studies will measure angiogenic factors in serum and plasma samples at baseline and on therapy. Tissue removed during surgical resection or blood removed prior to sclerotherapy will be used to obtain cells and tissue for the assessment of where biomarkers are coming from and to identify disease-causing pathways for new therapeutic targeting.

Conditions

• Vascular Anomaly
• Generalized Lymphatic Anomaly
• Kaposiform Hemangioendothelioma
• Kaposiform Lymphangiomatosis
• Gorham-Stout Disease
• Klippel Trenaunay Syndrome
• Congenital Lipomatous Overgrowth, Vascular Malformations, and Epidermal Nevi

Timeline

• Start date: 2015-04-01
• Primary completion: 2050-12-01
• Completion: 2050-12-01
• First posted: 2016-12-22
• Last updated: 2024-11-06

Locations

2 sites across 1 country: United States