Identification of Biomarkers for Patients With Vascular Anomalies

Vascular Anomaly Clinical Trial

Official title:

Identification of Biomarkers for Patients With Vascular Anomalies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03001180
• Other study ID #: CCHMC-LMI
• Status: Recruiting
• Start date: April 2015
• Est. completion date: December 2050

Study information

• Verified date: March 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Timothy LeCras, PhD
• Phone: 5138034862
• Email: hvmcresearch[@]cchmc.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2050
• Est. primary completion date: December 2050
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day and older

Eligibility

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.

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	CLOVES Syndrome Community Support Group, Klippel Trenaunay (KT) Support Group, Lymphangiomatosis and Gorham's Disease Alliance (LGDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of Biomarkers with Differential Diagnosis		An Average of Every 2 Years
Primary	Correlation of Biomarkers with Disease Severity		An Average of Every 2 Years
Primary	Correlation of Biomarkers with Response to Therapies		An Average of Every 2 Years