The long-term impact of immunotherapy and targeted therapy on outcomes in patients with brain metastases

Recruiting

• Conditions: Brain metastases; Cancer that has spread to the brain; 10027476; 10029211

• Registration Number: NL-OMON53728
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 72

Inclusion Criteria

- Any histologically confirmed stage IV solid primary cancer and radiologically
confirmed brain metastases;
- Adult patients: >=18 years of age;
- Treated with immunotherapy and/or targeted therapy (as monotherapy, combined
or in combination with other treatment modalities);
- Diagnosis of brain metastases >=2 years ago;
- Willing to provide written informed consent.

Exclusion Criteria

- Patients without understanding of the Dutch language, hampering the
completion of questionnaires or undergoing neurocognitive testing;
- Patients with a poor physical condition or any psychiatric condition or
cognitive impairment, as determined by the treating physician, that will hamper
them to provide consent to research or undergo neurocognitive testing or
completion of the questionnaires.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>- Neurocognitive functioning<br /><br>- Instrumental activities of daily living<br /><br>- Health-related quality of life<br /><br>- Epilepsy<br /><br>- Radiological abnormalities (cerebral abnormalities and treatment-induced<br /><br>radiological abnormalities)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Sociodemographic information (i.e. age at study assessments, gender, level of<br /><br>education, marital status and living arrangements, current or last profession)<br /><br>and clinical information (Karnofsky Performance Status, date of diagnosis<br /><br>primary cancer, relevant histological and molecular tumor information, sites of<br /><br>metastases, date of diagnosis brain metastases, number and location of brain<br /><br>metastases, previously received anti-tumor treatment and anti-tumor treatment<br /><br>at assessment, corticosteroid and antiepileptic drug use, and comorbidity).</p><br>