Arteriovenous Malformations Clinical Trial
Official title:
Validation of Core Biopsy of Vascular Anomalies for Clinical Pathology and Genomics
Verified date | April 2022 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this research is to gather information on the safety and effectiveness of core biopsy of vascular anomalies for clinical pathology and clinical genomics studies.
Status | Completed |
Enrollment | 3 |
Est. completion date | January 31, 2022 |
Est. primary completion date | January 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with a clinical and imaging diagnosis of a vascular anomaly. - No prior treatment for the vascular anomaly. - Subjects undergoing clinically indicated sclerotherapy, embolization and/or ablation. - Male or female with age greater than or equal to 18 years. - Capacity and willingness to provide a written informed consent.. Exclusion Criteria: - Subjects with prior treatment for their vascular anomaly. - Uncorrectable coagulopathy. - Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the procedure. |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adequacy of core biopsy of vascular anomalies for clinical genomics studies | DNA and RNA will be extracted from the biopsy specimens, undergo qualitative/quantitative quality control assessment and be analyzed by whole genome sequencing (DNA) and RNA sequence analysis (RNA-seq) to determine the adequacy of vascular anomaly biopsy for vascular anomaly genomics characterization. | 18 months | |
Primary | Adequacy of core biopsy of vascular anomalies for clinical pathology evaluation | Tissue from the vascular anomaly biopsies will undergo histopathology and immunohistochemical staining to determine the adequacy of vascular anomaly core biopsy for clinical pathology characterization. | 18 months | |
Secondary | Safety of vascular anomaly core biopsy | Number of participants with biopsy-related adverse events as assessed by CTCAE v4.0 | 30 days |
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