Skip to content

Brain Metastases in Norway - A Prospective Cohort Study

Brain Metastases in Norway - Improved Classification and Treatment. A Prospective Cohort Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03346655
Enrollment
3000
Registered
2017-11-17
Start date
2018-01-01
Completion date
2024-11-01
Last updated
2023-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Metastases

Keywords

Treatment

Brief summary

The overall aim and primary outcome of this study will be a descriptive analysis of the current treatment practice of BM in Norway. Specifically, it may give answers to the following research questions: * What is the true incidence of BM in Norway? * How are patients with BM treated at present? * Do treatments differ between hospitals? * How do treatments impact quality of life of the patients? * Which factors (treatment, tumor and host variables) can explain disease control, survival, symptom relief, and general functions? * How can BM staging be improved?

Interventions

None listed

Sponsors

Norwegian Cancer Society
CollaboratorOTHER
South-Eastern Norway Regional Health Authority
CollaboratorOTHER
Oslo University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Verified cancer diagnosis of solid tumors (based on radiological, histological/cytological or operative evidence). * Brain metastases verified by computer tomography (CT), contrast-enhanced magnetic resonance imaging (MRI), or surgical biopsies * Age ≥ 18 years * Able to comply with study procedures * Able to provide written informed consent after information in Norwegian

Exclusion criteria

* Primary brain tumors * Primary hematological malignancies (lymphomas, leukemias) * Previous diagnosis and/or treatment of BM * Unable to produce written informed consent after information in Norwegian

Design outcomes

Primary

MeasureTime frameDescription
Overall survival after diagnosis of brain metastasesTime from diagnosis of brain metastases till death of any cause, assessed up to 12 monthsCalculation of the overall survival times for each patient enrolled

Secondary

MeasureTime frameDescription
Treatment offered to patients diagnosed with brain metastases3 yearsDescription of treatment offered
Changes in patient reported symptoms and quality of life items through EORTC questionnaire QLQ PAL15 and submodule BN20Monthly up to 12 months after inclusionDescription of changes in patient reported outcomes through standardized questionnaires.European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer Patients receiving palliative care (EORTC QLQ-C15-PAL), covers items such as pain, physical and emotional functioning. The QLQ-BN20 contains questions on 7 single-item symptom scales (headaches, seizures, drowsiness, hair loss, itchy skin, leg weakness, and bladder control), and 4 multi-item scales (future uncertainty, visual disorder, motor dysfunction, and communication deficit). Patient's scores are translated into a scale from 1-100. A change of 10 points in one item is considered clinically significant.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026