Vascular Anomaly Pathology and Genomics Biopsy Study
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|ClinicalTrials.gov Identifier: NCT04836884|
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : April 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Vascular Malformations Vascular Anomaly Hemangioma Arteriovenous Malformations Venous Malformation Klippel Trenaunay Syndrome Lymphatic Malformation||Procedure: Percutaneous Vascular Anomaly/Malformation Biopsy||Not Applicable|
Vascular anomalies or vascular malformations often are treated with minimally invasive sclerotherapy, embolization or ablation based on clinical and imaging features without acquisition of tissue. Over the last two decades there have been significant advancements in the understanding of the genetic basis for various vascular anomalies/malformations, which may guide use of therapies for individualized treatment.
As such, given the emergence of novel medications for treatment of vascular anomalies/malformations based on genetic information, acquisition of tissue for pathology and genomic characterization will be increasingly important as treatment of vascular anomalies/vascular malformations moves toward individualized medicine approach.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Validation of Core Biopsy of Vascular Anomalies for Clinical Pathology and Genomics|
|Actual Study Start Date :||April 6, 2021|
|Estimated Primary Completion Date :||September 30, 2022|
|Estimated Study Completion Date :||September 30, 2022|
Experimental: Vascular anomaly/malformation biopsy
Subjects with a vascular anomaly will have a research percutaneous vascular anomaly/malformation biopsy completed at the time of the clinically indicated percutaneous sclerotherapy, embolization and/or ablation.
Procedure: Percutaneous Vascular Anomaly/Malformation Biopsy
US-guided percutaneous vascular anomaly core needle biopsy of up to 10 cores using an 18-gauge co-axial core needle biopsy device at the time of clinically indicated sclerotherapy, embolization or ablation treatment.
- Adequacy of core biopsy of vascular anomalies for clinical genomics studies [ Time Frame: 18 months ]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.
- Adequacy of core biopsy of vascular anomalies for clinical pathology evaluation [ Time Frame: 18 months ]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.
- Safety of vascular anomaly core biopsy [ Time Frame: 30 days ]Number of participants with biopsy-related adverse events as assessed by CTCAE v4.0
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): NCT04836884
|Contact: Desirae Howe-Clayton||507-255-0111||Howe.Desirae@mayo.edu|
|Contact: Scott Thompson, MD, PhD||507-284-2511||Thompson.Scott@mayo.edu|
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Emily Bendel, MD||Mayo Clinic|
|Principal Investigator:||David A Woodrum, MD, PhD||Mayo Clinic|