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

Phase 4

Recruiting

• Conditions: GIST; gastro intestinal stromacel tumor; kidney cancer; 10038364

• Registration Number: NL-OMON33283
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 80

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

-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

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>it is a pure describtive study, the results of the neuropsychological tests and<br /><br>the results of the lab tests of<br /><br>the different study groups will be compared</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>