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Evaluation of cognitive function of patients treated with sunitinib or sorafenib (UMCONCO200904

Evaluation of cognitive function of patients treated with sunitinib or sorafenib (UMCONCO200904 - Evaluation of cognitive function of patients with sunitinib or sorafenib

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON33283
Enrollment
80
Registered
2009-06-19
Start date
2009-07-24
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

GIST gastro intestinal stromacel tumor GIST kidney cancer

Interventions

None listed

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients: -patients with metastastic renal cell cancer or GIST who are on treatment with Sunitinib or Sorafenib for >= 8 weeks - Karnofsky score > 70% - age > 18 year. - written informed consent for study;Healthy controls selection: -Healthy individuals: - Karnofsky score > 70% - age > 18 year - written informed consent for study;Patient controls selection Inclusion criteria: -patients with metastastic renal cell cancer or GIST who aren*t treated yet (only interferon alfa or interleukine 2 treatment is allowed when > 12 months ago. - Karnofsky score > 70% - age > 18 year. - written informed consent for study

Exclusion criteria

Exclusion criteria: Patients: - contra-indications for treatment with Sunitinib or Sorafenib - patients who do not speak or write the Dutch language adequately - known brain metastasis - use of psychiatric or anti-epileptic medication - known cognitive disorders unrelated to diagnosis or medication use - radiotherapy on the brain at any time in the past - systemic chemotherapy - in the last 12 months interferon alfa or interleukine-2 treatment - operation in the last 6 months - Diabetes Mellitus - Stroke/TIA;Healthy controls section: - individuals who do not speak or write the Dutch language adequately - use of psychiatric or anti-epileptic medication - known cognitive disorders (Alzheimer e.g.) - radiotherapy on the brain at any time in the past - systemic chemotherapy - operation in the last 6 months - Diabetes Mellitus - stroke/TIA;Patient controls section: - patients who do not speak or write the Dutch language adequately - known brain metastasis - use of psychiatric or anti-epileptic medication - known cognitive disorders unrelated to diagnosis or medication use - radiotherapy on the brain at any time in the past - systemic chemotherapy - in the last 12 months interferon alfa or interleukine-2 treatment - operation in the last 6 months - Diabetes Mellitus - stroke/TIA

Design outcomes

Primary

MeasureTime frame
it is a pure describtive study, the results of the neuropsychological tests and the results of the lab tests of the different study groups will be compared

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)