An observational study in Vascular Anomaly, Generalized Lymphatic Anomaly and Kaposiform Hemangioendothelioma, sponsored by Children's Hospital Medical Center, Cincinnati. Recruiting at 2 sites in United States. Open to participants aged 1 Day and older. Per ClinicalTrials.gov, last updated 2024-11-06.
Sponsored by Children's Hospital Medical Center, Cincinnati · Observational
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.
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.
79 studies on the registry are indexed under Vascular Malformations; 33 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 200 across 27 observational studies indexed under Vascular Malformations.
Browse Vascular Malformations studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 673 studies on the registry; 130 are open to participants now.
Of its 57 completed or terminated interventional studies of FDA-regulated products, 31 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
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
Not enrolling at this site.
Plan to share: No
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Children's Hospital Medical Center, Cincinnati →