Identification of Biomarkers for Patients with Vascular Anomalies

Children's Hospital Medical Center, Cincinnati2 sites in 1 country1,000 target enrollmentApril 2015

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Vascular Anomaly
Sponsor: Children's Hospital Medical Center, Cincinnati
Enrollment: 1000
Locations: 2
Primary Endpoint: Correlation of Biomarkers with Differential Diagnosis
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 2015

End Date

December 2050

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Children's Hospital Medical Center, Cincinnati

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.