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Cognitive outcome after Gamma Knife Radiosurgery in patients with brain metastases

Cognitive outcome after Gamma Knife Radiosurgery in patients with brain metastases - Cognitive outcome after GKRS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON43670
Enrollment
100
Registered
2015-06-30
Start date
2015-10-28
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

cognitieve stoornissen Brain metastases brain tumor

Interventions

None listed

Sponsors

Sint Elisabeth Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Contrast enhanced volumetric MRI showing 1-10 newly diagnosed BM with a total tumor volume * 30cc * Lesion > 3 mm from optic apparatus* * Patient age * 18 years* * Karnofsky Performance Status * 70, WHO performance status * 2* * Anticipated survival (independent of the BM) greater than 3 months Dutch healthy control subjects will be: * Sociodemographically similar to the patient group * In good health, with no current or past psychiatric, neurologic, or cognitive disorder, and mediation-use that interferes with cognitive function

Exclusion criteria

Exclusion criteria: * No prior histologic confirmation of malignancy * Primary brain tumor, small cell lung cancer, lymphoma, leukemia, or meningeal disease * Progressive, symptomatic systemic disease without further treatment options * Prior brain radiation or surgical resection of BM * Additional history of a significant neurological or psychiatric disorder * Participation in a concurrent study in which neuropsychological testing and/or health-related QOL assessments are involved * Patients unable to complete test battery and/or study questionnaires due to any of the following reasons: lack of basic proficiency in Dutch, IQ below 85, severe aphasia, or paralysis

Design outcomes

Secondary

MeasureTime frame
* Fatigue (MFI) * Health related QOL (FACT-BR) * Depression and anxiety (HADS) * Overall Survival * Local and distant tumor control

Primary

MeasureTime frame
* Cognitive functioning as assessed with a battery of neuropsychological tests: The revised Hopkins Verbal Learning Test (HVLT-R), WAIS Digit Span and Digit Symbol, TMT A and B, COWA, and Grooved Pegboard

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)