Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-06 @ 1:25 PM
Study NCT ID:
NCT05267158
Status:
RECRUITING
Last Update Posted:
2022-09-06
First Post:
2021-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Cohort for Patient-reported Outcomes, Imaging and Trial Inclusion in Metastatic BRAin Disease (COIMBRA)
Sponsor:
UMC Utrecht
Organization:
Study Overview
Official Title:
The Cohort for Patient-reported Outcomes, Imaging and Trial Inclusion in Metastatic BRAin Disease (COIMBRA)
Status:
RECRUITING
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COIMBRA
Brief Summary:
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.
.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.
Detailed 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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: