Cohort for evaluating patient outcomes in brain metastases
The Cohort for Patient-reported Outcomes, Imaging and Trial Inclusion in Metastatic BRAin Disease (COIMBRA)
This study is trying to see how new treatments and MRI scans can help people with brain metastases by looking at their survival, symptoms, and quality of life while they receive regular care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT05267158 on ClinicalTrials.gov |
What this trial studies
This observational cohort aims to systematically evaluate new interventions and MRI sequences for patients with metastatic brain disease. It utilizes a cohort multiple randomized controlled trial (cmRCT) design to facilitate simultaneous evaluations of experimental treatments while collecting data on survival, symptoms, quality of life, cognition, and daily functioning. Patients will receive standard clinical care and will be followed prospectively to gather comprehensive outcome data.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed metastatic brain disease or those eligible for prophylactic cranial irradiation.
Not a fit: Patients with severe psychiatric disorders or cognitive dysfunction that impede their ability to consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of treatment impacts on quality of life and cognitive function for patients with brain metastases.
How similar studies have performed: Similar cohort designs have shown promise in evaluating treatment innovations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years; * Either radiographic and/or histologic proof of metastatic brain disease, or eligible for prophylactic cranial irradiation; * Referred to the Department of Radiotherapy for cranial irradiation. Exclusion Criteria: * Mental disorder or cognitive dysfunction that hinder the patient's ability to understand the informed consent procedure and/or study details; * Patients with severe psychiatric disorders; * Inability to understand the Dutch language.
Where this trial is running
Utrecht
- University Medical Center Utrecht — Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: Joost JC Verhoeff, MD, PhD — UMC Utrecht
- Study coordinator: Joost JC Verhoeff, MD, PhD
- Email: j.j.c.verhoeff-10@umcutrecht.nl
- Phone: +31-88-7564393
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.