Brain Metastases in Norway - A Prospective Cohort Study

NCT03346655 | Unknown

• 1 other identifier: 2017/1358
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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?

Conditions

Brain Metastases

Keywords

Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Treatment offered to patients diagnosed with brain metastases

  3 years

• Changes in patient reported symptoms and quality of life items through EORTC questionnaire QLQ PAL15 and submodule BN20

  Monthly up to 12 months after inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Norwegian Cancer Society: collaborator
• South-Eastern Norway Regional Health Authority: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biopsies

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Olav E Yri, MD

  Post-doc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Postdoctoral research fellow

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: November 17, 2017
• Study Start: January 1, 2018
• Primary Completion: March 31, 2022
• Study Completion: November 1, 2024
• Last Updated: November 3, 2023

Record last verified: 2023-11

Locations

NO (1)