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Identification of Biomarkers for Patients With Vascular Anomalies

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ClinicalTrials.gov Identifier: NCT03001180
Recruitment Status : Recruiting
First Posted : December 22, 2016
Last Update Posted : February 14, 2018
Sponsor:
Collaborators:
Lymphangiomatosis and Gorham's Disease Alliance (LGDA)
Boston Children’s Hospital
Klippel Trenaunay (KT) Support Group
CLOVES Syndrome Community Support Group
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:
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 or disease
Vascular Anomaly Generalized Lymphatic Anomaly Kaposiform Hemangioendothelioma Kaposiform Lymphangiomatosis Gorham-Stout Disease Klippel Trenaunay Syndrome Congenital Lipomatous Overgrowth, Vascular Malformations, and Epidermal Nevi

Detailed 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.

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Identification of Biomarkers for Patients With Vascular Anomalies
Study Start Date : April 2015
Estimated Primary Completion Date : January 2050





Primary Outcome Measures :
  1. Correlation of Biomarkers with Differential Diagnosis [ Time Frame: An Average of Every 2 Years ]
  2. Correlation of Biomarkers with Disease Severity [ Time Frame: An Average of Every 2 Years ]
  3. 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


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Ages Eligible for Study:   Child, Adult, Older Adult
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Klippel Trenaunay (KT) Support Group
CLOVES Syndrome Community Support Group
Investigators
Principal Investigator: Timothy LeCras, PhD Children's Hospital Medical Center, Cincinnati

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03001180     History of Changes
Other Study ID Numbers: CCHMC-LMI
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018

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:
Vascular Malformations
Klippel-Trenaunay-Weber Syndrome
Congenital Abnormalities
Hemangioendothelioma
Sarcoma, Kaposi
Kasabach-Merritt Syndrome
Osteolysis, Essential
Lipoma
Musculoskeletal Abnormalities
Nevus
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
Angiomatosis
Vascular Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Osteolysis