Identification of Biomarkers for Patients with Vascular Anomalies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Vascular Anomaly, Generalized Lymphatic Anomaly, Kaposiform Hemangioendothelioma, Kaposiform Lymphangiomatosis. Basic parameters: from 1 Day · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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. 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.
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]
Eligibility 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
- N/A
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 2 centers
- Boston Children's Hospital — Boston
- Cincinnati Children's Hospital Medical Center — Cincinnati
Identifiers
NCT: NCT03001180 · CCHMC-LMI