Identification of Biomarkers for Patients with Vascular Anomalies

NCT03001180 | Recruiting

• 1 other identifier: CCHMC-LMI
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Generalized Lymphatic Anomaly; Vascular Anomaly; Kaposiform Hemangioendothelioma; Kaposiform Lymphangiomatosis; Vascular Endothelial Growth Factor; Biomarkers; GLA; KLA; KHE; GSD

Outcome Measures

Primary Outcomes (3)

• Correlation of Biomarkers with Differential Diagnosis

  An Average of Every 2 Years

• Correlation of Biomarkers with Disease Severity

  An Average of Every 2 Years

• Correlation of Biomarkers with Response to Therapies

  An Average of Every 2 Years

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any participant having labs drawn as standard of care will have blood drawn for the study if consented/assented. All participants who are undergoing a surgical procedure or sclerotherapy are currently consented for participation in the tissue bank. The principle investigator will be looking at tissue from these participants. There is no further recruitment for the study.

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Lymphangiomatosis and Gorham's Disease Alliance (LGDA): collaborator
• Klippel Trenaunay (KT) Support Group: collaborator
• CLOVES Syndrome Community Support Group: collaborator

Study Sites (2)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

TERMINATED

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tissue, Blood, Plasma, and Serum Samples

MeSH Terms

Conditions

Vascular Malformations; Kaposiform Hemangioendothelioma; Osteolysis, Essential; Klippel-Trenaunay-Weber Syndrome; Congenital Lipomatous Overgrowth, Vascular Malformations, and Epidermal Nevi

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Osteolysis; Bone Resorption; Angiomatosis; Vascular Diseases

Study Officials

• Timothy LeCras, PhD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timothy LeCras, PhD

CONTACT

5138034862; hvmcresearch@cchmc.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 22, 2016
• Study Start: April 1, 2015
• Primary Completion (Estimated): December 1, 2050
• Study Completion (Estimated): December 1, 2050
• Last Updated: November 6, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)