Brain Metastases in Norway - A Prospective Cohort Study

Brain Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03346655
• Other study ID #: 2017/1358
• Status: Active, not recruiting
• Start date: January 1, 2018
• Est. completion date: November 1, 2024

Study information

• Verified date: November 2023
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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?

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3000
• Est. completion date: November 1, 2024
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	Norwegian Cancer Society, South-Eastern Norway Regional Health Authority

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival after diagnosis of brain metastases	Calculation of the overall survival times for each patient enrolled	Time from diagnosis of brain metastases till death of any cause, assessed up to 12 months
Secondary	Treatment offered to patients diagnosed with brain metastases	Description of treatment offered	3 years
Secondary	Changes in patient reported symptoms and quality of life items through EORTC questionnaire QLQ PAL15 and submodule BN20	Description 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.	Monthly up to 12 months after inclusion