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Vascular Anomaly Pathology and Genomics Biopsy Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04836884
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Emily C. Bendel, M.D., Mayo Clinic

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.

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
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


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Safety of vascular anomaly core biopsy [ Time Frame: 30 days ]
    Number of participants with biopsy-related adverse events as assessed by CTCAE v4.0



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Desirae Howe-Clayton 507-255-0111 Howe.Desirae@mayo.edu
Contact: Scott Thompson, MD, PhD 507-284-2511 Thompson.Scott@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Emily Bendel, MD Mayo Clinic
Principal Investigator: David A Woodrum, MD, PhD Mayo Clinic
Additional Information:
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Responsible Party: Emily C. Bendel, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04836884    
Other Study ID Numbers: 20-011265
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemangioma
Lymphangioma
Arteriovenous Malformations
Vascular Malformations
Klippel-Trenaunay-Weber Syndrome
Lymphatic Abnormalities
Congenital Abnormalities
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Lymphatic Vessel Tumors
Lymphatic Diseases
Angiomatosis