Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry
- Conditions
- CNS Tumor
- Registration Number
- NCT02684838
- Lead Sponsor
- Arbor Pharmaceuticals, Inc.
- Brief Summary
This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care.
- Detailed Description
This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care. Data will be collected on the safety and effectiveness of treatment with Gliadel Wafer perioperatively and ongoing during regular office visits up to 3-years. Patients enrolled in this registry will be asked to complete a questionnaire (Functional Assessment of Cancer Therapy-Brain \[FACT-Br\]) about their well-being and clinicians will complete the Karnofsky Performance Status (KPS) during office visits.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 272
- Signed informed consent, by the patient or a legally acceptable representative, obtained before any registry-related activities are undertaken. The informed consent must be signed within 14 calendar days after surgery.
- Male and female patients, greater than or equal to 18 years of age or age of majority in state of residence.
- Patients planning to receive Gliadel Wafer, or having already received Gliadel Wafer and having signed consent to enroll in the registry within 14 calendar days after surgery for treatment of central nervous system (CNS) tumor(s), or are currently enrolled in another study where they received Gliadel Wafer.
- Signed release form, by the patient or a legally acceptable representative, permitting abstraction of the patient's medical records at Baseline and during participation in the registry.
- The patient is enrolled in an interventional clinical trial, in which treatment for CNS tumor(s) is managed through a protocol that excludes Gliadel Wafer treatment.
- Any abnormality or medical condition that, at the discretion of the Investigator, may put the patient at increased risk by participating in this registry.
- Any other reason that, in the Investigator's opinion, makes the patient unsuitable to participate in this registry.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the overall survival rate for patients treated with Gliadel Wafer up to 3 years Time from Gliadel placement to death
To evaluate the progression-free survival rate for patients treated with Gliadel Wafer up to 3 years Time from Gliadel placement to diagnosis of recurrent CNS tumor
To evaluate the disease-specific survival rate for patients treated with Gliadel Wafer up to 3 years Time from Gliadel placement to death due to CNS tumor
- Secondary Outcome Measures
Name Time Method To evaluate nonserious, suspected adverse drug reactions (ADRs) in patients treated with Gliadel Wafer. up to 3 years frequency of ADRs
To evaluate change in patient health status over time via patient reported outcomes (PRO) up to 3 years Change in FACT-Br score from baseline to end of study participation
To evaluate the serious adverse events (SAEs) in patients treated with Gliadel Wafer. up to 3 years Frequency of SAEs
To evaluate change in patient health status over time via a practitioner/proxy reported scale up to 3 years Change in KPS score from baseline to end of study participation
To evaluate the the reasons a physician does not insert Gliadel Wafers, in patients who were considered and consented for this Registry prior to the tumor resection procedure up to 3 years reasons for screen failure
To evaluate events of interest (EOI) in patients treated with Gliadel Wafer. up to 3 years Frequency of EOIs
Trial Locations
- Locations (31)
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Crouse Neuroscience Institute
🇺🇸Syracuse, New York, United States
Beacon Medical Group
🇺🇸Elkhart, Indiana, United States
Albany Medical Center Hospital
🇺🇸Albany, New York, United States
Baptist Health Paducah
🇺🇸Paducah, Kentucky, United States
University of Pennsylvania Health System
🇺🇸Philadelphia, Pennsylvania, United States
Johns Hopkins University School of Medicine
🇺🇸Baltimore, Maryland, United States
Vidant Medical Center
🇺🇸Greenville, North Carolina, United States
Wake Forest Baptist Med Center
🇺🇸Winston-Salem, North Carolina, United States
Spine and Neuro Center
🇺🇸Huntsville, Alabama, United States
McLaren Bay Neurology Associates
🇺🇸Bay City, Michigan, United States
Depaul Hospital
🇺🇸Bridgeton, Missouri, United States
St. Louis University Hospital
🇺🇸Saint Louis, Missouri, United States
Brain Tumor Center
🇺🇸Lake Success, New York, United States
Neurological Associates of Tucson, DBA Center for Neurosciences
🇺🇸Tucson, Arizona, United States
Oschner Medical Center
🇺🇸New Orleans, Louisiana, United States
Spine Group Arizona At Honorhealth Scottsdale Osborn Medical Center
🇺🇸Scottsdale, Arizona, United States
David Geffen School of Medicine at UCLA; Departments of Neurosurgery and Pathology at the
🇺🇸Los Angeles, California, United States
Jfk Medical Center
🇺🇸Edison, New Jersey, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Grand Strand Medical Center
🇺🇸Myrtle Beach, South Carolina, United States
Mount Carmel Neurosurgery
🇺🇸Columbus, Ohio, United States
Borrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
University of California, San Francisco Department of Neurological Surgery
🇺🇸San Francisco, California, United States
University of Colorado School of Medicine
🇺🇸Aurora, Colorado, United States
Baycare Medical Group
🇺🇸Tampa, Florida, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Western Regional Ctr for Brain and Spine Surgery
🇺🇸Las Vegas, Nevada, United States
University of Oklahoma - Stevenson Cancer Center
🇺🇸Oklahoma City, Oklahoma, United States
University of Washington School of Medicine
🇺🇸Seattle, Washington, United States