Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02684838

Acronym

VIGILANT

Enrollment

272

Registered

2016-02-18

Start date

2016-04-26

Completion date

2025-06-23

Last updated

2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CNS Tumor

Keywords

Gliadel, Carmustine wafer implant

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. 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. 2. Male and female patients, greater than or equal to 18 years of age or age of majority in state of residence. 3. 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. 4. 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.

Exclusion criteria

1. 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. 2. Any abnormality or medical condition that, at the discretion of the Investigator, may put the patient at increased risk by participating in this registry. 3. Any other reason that, in the Investigator's opinion, makes the patient unsuitable to participate in this registry.

Design outcomes

Primary

Measure	Time frame	Description
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
To evaluate the overall survival rate for patients treated with Gliadel Wafer	up to 3 years	Time from Gliadel placement to death

Secondary

Measure	Time frame	Description
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 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 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 events of interest (EOI) in patients treated with Gliadel Wafer.	up to 3 years	Frequency of EOIs

Other

Measure	Time frame	Description
To evaluate health care utilization though length of hospital stays for the primary procedure and any subsequent hospitalizations in patients treated with Gliadel Wafer	up to 3 years	number of days in hospital following Gliadel insertion
To explore patient survival status based upon biomarker status.	up to 3 years	—

Countries

United States

Outcome results