IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
Trial record 5 of 10 for:
"Hemangioendothelioma"
Identification of Biomarkers for Patients With Vascular Anomalies
This study is currently recruiting participants.
Verified April 2017 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborators:
Lymphangiomatosis and Gorham's Disease Alliance (LGDA)
Boston Children’s Hospital
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT03001180
First received: December 15, 2016
Last updated: April 26, 2017
Last verified: April 2017
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The study will use participants tissue previously collected and stored in a tissue bank maintained by the Department of Hematology/Oncology as well as tissue banked in the future from participants undergoing prescribed surgical resection of vascular anomalies of interest proposed in this study. The principle investigator and study staff will also obtain blood from these participants.
| Condition |
|---|
| Vascular Anomaly Generalized Lymphatic Anomaly Kaposiform Hemangioendothelioma Kaposiform Lymphangiomatosis Gorham-Stout Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Control Time Perspective: Cross-Sectional |
| Official Title: | Identification of Biomarkers for Patients With Vascular Anomalies |
Resource links provided by NLM:
Genetics Home Reference related topics:
Parkes Weber syndrome
capillary malformation-arteriovenous malformation syndrome
Genetic and Rare Diseases Information Center resources:
Hemangioendothelioma
Kaposiform Hemangioendothelioma
Lymphangiomatosis
Gorham's Disease
Soft Tissue Sarcoma
Hemangioma Thrombocytopenia Syndrome
U.S. FDA Resources
Further study details as provided by Children's Hospital Medical Center, Cincinnati:
Primary Outcome Measures:
- 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 ]
Biospecimen Retention: Samples With DNA
Tissue, Blood, Plasma, and Serum Samples
| Estimated Enrollment: | 1000 |
| Study Start Date: | April 2015 |
| Estimated Primary Completion Date: | January 2050 (Final data collection date for primary outcome measure) |
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. Identification of VEGF-D as a biomarker in LAM (Lymphangiomyomatosis) patients is an excellent example of how a blood biomarker can impact diagnosis and treatment. Biomarkers may also give insights into disease pathogenesis, as often they are released by cells that contribute to the disease process. The studies in this protocol will characterize and define biomarkers to aid in the diagnosis and treatment of patients with vascular anomalies. The differential diagnosis of some of these entities can be challenging, especially GLA versus KLA and KLA versus KHE. 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.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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.
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.
Exclusion Criteria:
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03001180
Please refer to this study by its ClinicalTrials.gov identifier: NCT03001180
Contacts
| Contact: Timothy LeCras, PhD | 5138034862 | hvmcresearch@cchmc.org | |
| Contact: Paula Mobberley-Schuman | 5138034862 | hvmcresearch@cchmc.org |
Locations
| United States, Massachusetts | |
| Boston Children's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Justyna Klajn 617-355-2901 justyna.klajn@childrens.harvard.edu | |
| Contact: Denise Adams, MD 617-919-1761 denise.adams@childrens.harvard.edu | |
| Principal Investigator: Denise Adams, MD | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | Recruiting |
| Cincinnati, Ohio, United States, 45229 | |
| Contact: Paula Mobberley-Schuman, MS 513-803-4862 hvmcresearch@cchmc.org | |
| Principal Investigator: Timothy LeCras, PhD | |
| Sub-Investigator: Adrienne Hammill, MD, PhD | |
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Lymphangiomatosis and Gorham's Disease Alliance (LGDA)
Boston Children’s Hospital
Investigators
| Principal Investigator: | Timothy LeCras, PhD | Children's Hospital Medical Center, Cincinnati |
More Information
| Responsible Party: | Children's Hospital Medical Center, Cincinnati |
| ClinicalTrials.gov Identifier: | NCT03001180 History of Changes |
| Other Study ID Numbers: |
CCHMC-LMI |
| Study First Received: | December 15, 2016 |
| Last Updated: | April 26, 2017 |
Keywords provided by Children's Hospital Medical Center, Cincinnati:
|
Generalized Lymphatic Anomaly Vascular Anomaly Kaposiform Hemangioendothelioma Kaposiform Lymphangiomatosis Vascular Endothelial Growth Factor |
Biomarkers GLA KLA KHE GSD |
Additional relevant MeSH terms:
|
Hemangioendothelioma Congenital Abnormalities Vascular Malformations Sarcoma, Kaposi Kasabach-Merritt Syndrome Osteolysis, Essential Cardiovascular Abnormalities Cardiovascular Diseases Hemangioma Neoplasms, Vascular Tissue Neoplasms by Histologic Type Neoplasms Herpesviridae Infections |
DNA Virus Infections Virus Diseases Sarcoma Neoplasms, Connective and Soft Tissue Thrombocytopenia Blood Platelet Disorders Hematologic Diseases Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Osteolysis Bone Resorption |
ClinicalTrials.gov processed this record on July 14, 2017