Brain Metastases in Norway - A Prospective Cohort Study

November 2, 2023 updated by: Olav Erich Yri, Oslo University Hospital

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

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?

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Oslo University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients With previously or newly diagnosed cancer With radiologically proven brain metastases

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival after diagnosis of brain metastases
Time Frame: Time from diagnosis of brain metastases till death of any cause, assessed up to 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment offered to patients diagnosed with brain metastases
Time Frame: 3 years
Description of treatment offered
3 years
Changes in patient reported symptoms and quality of life items through EORTC questionnaire QLQ PAL15 and submodule BN20
Time Frame: Monthly up to 12 months after inclusion
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Norwegian Cancer Society
South-Eastern Norway Regional Health Authority

Investigators

  • Principal Investigator: Olav E Yri, MD, Post-doc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

March 31, 2022

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

November 7, 2017

First Submitted That Met QC Criteria

November 14, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Estimated)

November 3, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/1358

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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