Vascular Anomaly Pathology and Genomics Biopsy Study

NCT04836884 | Completed

• 1 other identifier: 20-011265
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vascular Malformations; Vascular Anomaly; Hemangioma; Arteriovenous Malformations; Venous Malformation; Klippel Trenaunay Syndrome; Lymphatic Malformation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Safety of vascular anomaly core biopsy

  30 days

Study Arms (1)

Vascular anomaly/malformation biopsy

EXPERIMENTAL

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

Interventions

Percutaneous Vascular Anomaly/Malformation Biopsy PROCEDURE

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.

Vascular anomaly/malformation biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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..

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Vascular Malformations; Hemangioma; Arteriovenous Malformations; Klippel-Trenaunay-Weber Syndrome; Lymphatic Abnormalities

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms; Vascular Diseases; Angiomatosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Emily Bendel, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• David A Woodrum, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 8, 2021
• Study Start: April 6, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: April 21, 2022

Record last verified: 2022-04

Locations

US (1)