NCT02445430

Brief Summary

The goal of this study is to identify genetic alterations resulting in the development of arteriovenous malformation (AVM) in the central nervous system.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 15, 2015

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

7.2 years

First QC Date

May 11, 2015

Last Update Submit

September 20, 2021

Conditions

Arteriovenous Malformation

Outcome Measures

Primary Outcomes (1)

  • Identification of genetic alterations common to patients with AVM

    sample analysis will take an expected average of six weeks

Eligibility Criteria

Age6 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Male and female persons with AVM and their immediate family members

You may qualify if:

  • Age between 6 and 60 years inclusive
  • Diagnosis of AVM or nuclear family member of a patient with AVM
  • Grants access to saliva, blood, and/or tissue

You may not qualify if:

  • Age less than 6 years or greater than 61 years
  • Nuclear family members who do not share the same parents as the AVM patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva, blood, tissue (if undergoing AVM resection)

MeSH Terms

Conditions

Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Vascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Joseph Zabramski, MD

    Barrow Neurosurgical Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Manager

Study Record Dates

First Submitted

May 11, 2015

First Posted

May 15, 2015

Study Start

May 1, 2015

Primary Completion

June 30, 2022

Study Completion

June 30, 2023

Last Updated

September 21, 2021

Record last verified: 2021-09

Locations

US(1)