Vascular MalformationsNCT04836884
Vascular Anomaly Pathology and Genomics Biopsy Study
A study testing Percutaneous Vascular Anomaly/Malformation Biopsy in people with Vascular Malformations and Vascular Anomaly, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Malformations, Vascular Anomaly, Hemangioma
- What is being tested?
- Percutaneous Vascular Anomaly/Malformation Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2021to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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..
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Validation of Core Biopsy of Vascular Anomalies for Clinical Pathology and Genomics
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.
Read the 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.
- Conditions
- Vascular Malformations, Vascular Anomaly, Hemangioma, Arteriovenous Malformations, Venous Malformation, Klippel Trenaunay Syndrome
- Being tested
- Percutaneous Vascular Anomaly/Malformation Biopsy
- Medical subject headings
- Vascular Malformations, Hemangioma, Arteriovenous Malformations, Klippel-Trenaunay-Weber Syndrome, Lymphatic Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Vascular Anomaly/Malformation BiopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Percutaneous Vascular Anomaly/Malformation Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 18 months
Secondary outcomes (1)
Safety of vascular anomaly core biopsy
Number of participants with biopsy-related adverse events as assessed by CTCAE v4.0
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start6 Apr 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular MalformationsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily C. Bendel, M.D., Mayo Clinic
- Investigators
- Emily Bendel, MD, Principal investigator, Mayo ClinicDavid A Woodrum, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836884
- Sponsor's protocol ID
- 20-011265
- Status last verified
- Apr 2022
- First submitted
- 25 Mar 2021
- Last updated
- 21 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Core Biopsy of Vascular Anomalies for Clinical Pathology and Genomics
- ClinicalTrials.gov ID
- NCT04836884
- Acronym / sponsor ID
- 20-011265
- Conditions
- Vascular Malformations, Vascular Anomaly, Hemangioma, Arteriovenous Malformations, Venous Malformation, Klippel Trenaunay Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vascular anomaly/malformation biopsy | Experimental | Procedure: Percutaneous Vascular Anomaly/Malformation BiopsySubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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..
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Vascular Anomaly/Malformation BiopsyUS-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. | Procedure or surgery | Vascular anomaly/malformation biopsy |
Primary outcome
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.
1 secondary outcome
Safety of vascular anomaly core biopsy
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Bendel, MD principal investigator
Mayo Clinic
David A Woodrum, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Vascular Anomaly/Malformation Biopsy in people with Vascular Malformations and Vascular Anomaly, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequacy of core biopsy of vascular anomalies for clinical genomics studies (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.