Recruiting

Biomarkers

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT03001180

Conditions

Vascular Anomaly

Generalized Lymphatic Anomaly

Kaposiform Hemangioendothelioma

Kaposiform Lymphangiomatosis

Gorham-Stout Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT03001180

Start date

Apr, 2015

Status verified date

Oct, 2024

Completion date

Dec, 2050

Anticipated

Primary completion date

Dec, 2050

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Timothy LeCras, PhD

5138034862hvmcresearch@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Megan Metcalf

513-803-2606hvmcresearch@cchmc.org

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Nov 6, 2024

Last verified

Oct, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2024-11-06.