Identification of Biomarkers for Patients with Vascular Anomalies

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.

Recruiting

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Key information

Conditions

Vascular Anomaly Angiomatosis Bone Diseases Bone Diseases, Developmental Bone Resorption Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital Lipomatous Overgrowth, Vascular Malformations, and Epidermal Nevi Congenital, Hereditary, and Neonatal Diseases and Abnormalities Generalized Lymphatic Anomaly Gorham-Stout Disease Kaposiform Hemangioendothelioma Kaposiform Lymphangiomatosis Klippel Trenaunay Syndrome Klippel-Trenaunay-Weber Syndrome Musculoskeletal Diseases Osteolysis Osteolysis, Essential Vascular Diseases Vascular Malformations

Age range

1 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital, Boston, Massachusetts, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Correlation of Biomarkers with Differential Diagnosis

Time frame: An Average of Every 2 Years
Correlation of Biomarkers with Disease Severity

Time frame: An Average of Every 2 Years
Correlation of Biomarkers with Response to Therapies

Time frame: An Average of Every 2 Years

Study contacts

Contact information is provided by the study sponsor or research team.

Timothy LeCras, PhD

CONTACT

[email protected]

5138034862

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

CLOVES Syndrome Community Support Group
Klippel Trenaunay (KT) Support Group
Lymphangiomatosis and Gorham's Disease Alliance (LGDA)

Registry information

Important dates

Study start: 2015
Primary completion: 2050
Study completion: 2050
First posted: Dec 22, 2016
Registry last updated: Nov 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed