Vigilant ObservatIon of GlIadeL WAfer ImplaNT Registry (VIGILANT)

A

Arbor Pharmaceuticals

Status

Active, not recruiting

Conditions

CNS Tumor

Study type

Observational

Funder types

Industry

Identifiers

NCT02684838
AR22.001

Details and patient eligibility

About

This is a prospective, observational registry in patients who have been prescribed Gliadel Wafer by the physician as part of usual care.

Full 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.

Enrollment

272 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial contacts and locations

31

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Data sourced from clinicaltrials.gov

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