RECRUITING

Treatment of Brain AVMs (TOBAS) Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The objectives of this study and registry are to offer the best management possible for patients with brain arteriovenous malformations (AVMs) (ruptured or unruptured) in terms of long-term outcomes, despite the presence of uncertainty. Management may include interventional therapy (with endovascular procedures, neurosurgery, or radiotherapy, alone or in combination) or conservative management. The trial has been designed to test a) whether medical management or interventional therapy will reduce the risk of death or debilitating stroke (due to hemorrhage or infarction) by an absolute magnitude of about 15% (over 10 years) for unruptured AVMs (from 30% to 15%); and, b) to test if endovascular treatment can improve the safety and efficacy of surgery or radiation therapy by at least 10% (80% to 90%). As for the nested trial on the role of embolization in the treatment of Brain AVMs by other means: the pre-surgical or pre-radiosurgery embolization of cerebral AVMs can decrease the number of treatment failures from 20% to 10%. In addition,embolization of cerebral AVMs can be accomplished with an acceptable risk, defined as permanent disabling neurological complications of 8%.

Official Title

Treatment of Brain AVMs (TOBAS) Study: A Randomized Controlled Trial and Registry

Quick Facts

Study Start:2014-05
Study Completion:2036-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02098252

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Any patient with a brain AVM
  1. * Hemorrhagic presentation with mass effect requiring surgical management. In these cases, if a residual AVM is found after the initial surgery, the patient could then be a candidate for TOBAS.

Contacts and Locations

Study Contact

Daniel Roy, MD
CONTACT
514-890-8000
daniel.roy.chum@ssss.gouv.qc.ca
Tim Darsaut, MD
CONTACT
780-407-1440
tdarsaut@ualberta.ca

Principal Investigator

Daniel Roy, MD
PRINCIPAL_INVESTIGATOR
CHUM-Montreal

Study Locations (Sites)

Mayo Clinic in Jacksonville FL
Jacksonville, Florida
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, 87131
United States

Collaborators and Investigators

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

  • Daniel Roy, MD, PRINCIPAL_INVESTIGATOR, CHUM-Montreal

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2014-05
Study Completion Date2036-01

Study Record Updates

Study Start Date2014-05
Study Completion Date2036-01

Terms related to this study

Keywords Provided by Researchers

  • brain arteriovenous malformation
  • Arteriovenous Malformations
  • AVM
  • BAVM
  • Stroke
  • Intracranial Hemorrhage
  • Congenital Abnormalities
  • Aneurysm
  • Vascular Malformations
  • Cardiovascular Abnormalities
  • Cardiovascular Diseases
  • Vascular Diseases

Additional Relevant MeSH Terms

  • Unruptured Brain Arteriovenous Malformation
  • Ruptured Brain Arteriovenous Malformation
  • Arteriovenous Malformations
  • AVM
  • BAVM