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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 : March 14, 2019
Sponsor:
Collaborators:
Norwegian Cancer Society
South-Eastern Norway Regional Health Authority
Information provided by (Responsible Party):
Olav Erich Yri, Oslo University Hospital

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?

Condition or disease
Brain Metastases

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Treatment offered to patients diagnosed with brain metastases [ Time Frame: 3 years ]
    Description of treatment offered

  2. Changes in patient reported symptoms and quality of life items through EORTC questionnaire QLQ PAL15 [ Time Frame: Monthly up to 12 months after inclusion ]
    Description of changes in patient reported outcomes through standardized questionnaires

  3. Changes in patient reported symptoms through EORTC questionnaire BN20 [ Time Frame: Monthly up to 12 months after inclusion ]
    Description of changes in patient reported outcomes through standardized questionnaires


Biospecimen Retention:   Samples With DNA
Biopsies


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients With previously or newly diagnosed cancer With radiologically proven brain metastases
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Stein Kaasa, Professor +47 22 93 40 00 stekaa@ous-hf.no
Contact: Marianne Jensen Hjermstad, Professor +47 23 02 68 28 marianne.j.hjermstad@ntnu.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Olav E Yri, MD, PhD    +47 22 93 40 00    olavy@ous-hf.no   
Contact: Marianne Jensen Hjermstad, Professor    +47 23 02 68 28    marianne.j.hjermstad@ntnu.no   
Sponsors and Collaborators
Oslo University Hospital
Norwegian Cancer Society
South-Eastern Norway Regional Health Authority
Investigators
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Principal Investigator: Olav E Yri, MD Post-doc

Additional Information:

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Responsible Party: Olav Erich Yri, MD, PhD, Postdoctoral research fellow, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03346655     History of Changes
Other Study ID Numbers: 2017/1358
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Olav Erich Yri, Oslo University Hospital:
Treatment
Additional relevant MeSH terms:
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Neoplasm Metastasis
Brain Neoplasms
Brain Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Central Nervous System Diseases
Nervous System Diseases