A Study of Avapritinib in Pediatric Patients With Solid Tumors Dependent on KIT or PDGFRA Signaling
NCT04773782
CNS Tumor, Central Nervous System Neoplasms
Phoenix, Arizona, United States
View Trial DetailsNCT Number: NCT02684838
This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Spine and Neuro Center, Huntsville, Alabama, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: up to 3 years
Time from Gliadel placement to death
Time frame: up to 3 years
Time from Gliadel placement to death due to CNS tumor
Time frame: up to 3 years
Time from Gliadel placement to diagnosis of recurrent CNS tumor
Time frame: up to 3 years
Frequency of SAEs
Time frame: up to 3 years
Frequency of EOIs
Time frame: up to 3 years
frequency of ADRs
Time frame: up to 3 years
Change in FACT-Br score from baseline to end of study participation
Time frame: up to 3 years
Change in KPS score from baseline to end of study participation
Time frame: up to 3 years
reasons for screen failure
Time frame: up to 3 years
number of days in hospital following Gliadel insertion
Time frame: up to 3 years
Arbor Pharmaceuticals, Inc.
Industry
Vigilant ObservatIon of GlIadeL WAfer ImplaNT (VIGILANT) Registry: A Multicenter, Observational Registry to Collect Information on the Safety and Effectiveness of Gliadel® Wafer (Carmustine Implant) Used in Usual Medical Practice
Acronym: VIGILANT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04773782
CNS Tumor, Central Nervous System Neoplasms
Phoenix, Arizona, United States
View Trial DetailsNCT06322342
Acoustic Neuroma, Autoimmune Diseases
New Haven, Connecticut, United States
View Trial DetailsNCT04023669
Brain Cancer, Brain Diseases
Memphis, Tennessee, United States
View Trial DetailsNCT03434262
Anaplastic Astrocytoma, Anaplastic Ependymoma
Memphis, Tennessee, United States
View Trial Details