Brain Metastases in Norway - A Prospective Cohort Study
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|ClinicalTrials.gov Identifier: NCT03346655|
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : February 25, 2021
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?
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||3000 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Brain Metastases in Norway - Improved Classification and Treatment. A Prospective Cohort Study|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||January 1, 2023|
- 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
- Treatment offered to patients diagnosed with brain metastases [ Time Frame: 3 years ]Description of treatment offered
- 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03346655
|Contact: Stein Kaasa, Professor||+47 22 93 40 email@example.com|
|Contact: Marianne Jensen Hjermstad, Professor||+47 23 02 68 firstname.lastname@example.org|
|Principal Investigator:||Olav E Yri, MD||Post-doc|