The Cohort for Patient-reported Outcomes, Imaging and Trial Inclusion in Metastatic BRAin Disease (COIMBRA)

UMC Utrecht

Status: Enrolling

Conditions: Brain Metastases, Adult; Brain Neoplasms, Adult, Malignant

Study type: Observational

Funder types: Other

Identifiers

NCT05267158

NL67206.041.18

Details and patient eligibility

About

The incidence of brain metastases is expected to increase because of better treatments of primary tumours. Novel diagnostic and therapeutic techniques are continuously being developed, all of which need thorough evaluation before they can be implemented in clinical routine. Randomized Controlled Trials are the gold standard to do so, but they have shown many challenges, especially when applied in a cancer setting.

.The 'cohort multiple Randomized Controlled Trial (cmRCT)' design is a promising design for multiple (simultaneous) randomized evaluations of experimental interventions, with potential for increased recruitment, comparability and long-term outcomes as a standard. This design will speed up the process of translating treatment innovations to the daily clinic.

Full description

The COIMBRA cohort is a prospective cohort, which will serve as a facility for efficient, systematic and simultaneous evaluation of new interventions and MRI sequences and prospective outcome studies (including prediction modelling).

COIMBRA patients will be followed prospectively and information on survival, symptoms, QoL (patient and caregiver), cognition, toxicity and daily functioning in relation to treatment will be collected prospectively.

Patients will receive the regular optimal clinical care according to the current guidelines when not participating in cmRCT's.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.