Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the overall survival rate for patients treated with Gliadel Wafer | Time from Gliadel placement to death | up to 3 years |
| To evaluate the disease-specific survival rate for patients treated with Gliadel Wafer | Time from Gliadel placement to death due to CNS tumor | up to 3 years |
| To evaluate the progression-free survival rate for patients treated with Gliadel Wafer | Time from Gliadel placement to diagnosis of recurrent CNS tumor | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the serious adverse events (SAEs) in patients treated with Gliadel Wafer. | Frequency of SAEs | up to 3 years |
| To evaluate events of interest (EOI) in patients treated with Gliadel Wafer. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate health care utilization though length of hospital stays for the primary procedure and any subsequent hospitalizations in patients treated with Gliadel Wafer | number of days in hospital following Gliadel insertion | up to 3 years |
| To explore patient survival status based upon biomarker status. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients who have been prescribed Gliadel Wafer by the physician as part of usual care
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spine and Neuro Center | Huntsville | Alabama | 35801 | United States | ||
| Borrow Neurological Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29206049 | Derived | Lillehei KO, Kalkanis SN, Liau LM, Mydland DE, Olson J, Paleologos NA, Ryken T, Johnson T, Scullin E. Rationale and design of the 500-patient, 3-year, and prospective Vigilant ObservatIon of GlIadeL WAfer ImplaNT registry. CNS Oncol. 2018 Apr;7(2):CNS08. doi: 10.2217/cns-2017-0036. Epub 2017 Dec 5. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Available biomarker data will be collected (e.g., MGMT, EGFR, and IDH 1&2) and exploratory patient survival analysis will be conducted based upon biomarker status.
Frequency of EOIs
| up to 3 years |
| To evaluate nonserious, suspected adverse drug reactions (ADRs) in patients treated with Gliadel Wafer. | frequency of ADRs | up to 3 years |
| To evaluate change in patient health status over time via patient reported outcomes (PRO) | Change in FACT-Br score from baseline to end of study participation | up to 3 years |
| To evaluate change in patient health status over time via a practitioner/proxy reported scale | Change in KPS score from baseline to end of study participation | up to 3 years |
| 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 | reasons for screen failure | up to 3 years |
| up to 3 years |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Spine Group Arizona At Honorhealth Scottsdale Osborn Medical Center | Scottdale | Arizona | 85251 | United States |
| Neurological Associates of Tucson, DBA Center for Neurosciences | Tucson | Arizona | 85718 | United States |
| David Geffen School of Medicine at UCLA; Departments of Neurosurgery and Pathology at the | Los Angeles | California | 90095 | United States |
| University of California, San Francisco Department of Neurological Surgery | San Francisco | California | 94143 | United States |
| University of Colorado School of Medicine | Aurora | Colorado | 80045 | United States |
| Baycare Medical Group | Tampa | Florida | 33607 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Beacon Medical Group | Elkhart | Indiana | 46530 | United States |
| Baptist Health Paducah | Paducah | Kentucky | 42003 | United States |
| Oschner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | United States |
| McLaren Bay Neurology Associates | Bay City | Michigan | 48707 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Depaul Hospital | Bridgeton | Missouri | 63044 | United States |
| St. Louis University Hospital | St Louis | Missouri | 63110 | United States |
| Western Regional Ctr for Brain and Spine Surgery | Las Vegas | Nevada | 89102 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Jfk Medical Center | Edison | New Jersey | 08820 | United States |
| Albany Medical Center Hospital | Albany | New York | 12208 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| Brain Tumor Center | Lake Success | New York | 11042 | United States |
| Crouse Neuroscience Institute | Syracuse | New York | 13210 | United States |
| Vidant Medical Center | Greenville | North Carolina | 27834 | United States |
| Wake Forest Baptist Med Center | Winston-Salem | North Carolina | 27157 | United States |
| Mount Carmel Neurosurgery | Columbus | Ohio | 43222 | United States |
| University of Oklahoma - Stevenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | United States |
| Grand Strand Medical Center | Myrtle Beach | South Carolina | 39572 | United States |
| University of Washington School of Medicine | Seattle | Washington | 98195 | United States |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
Not provided
Not provided