Brain MetastasesNCT03346655
Brain Metastases in Norway - A Prospective Cohort Study
An observational study of Brain Metastases, run by Oslo University Hospital at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases
- How many people
- 3,000 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2018to 1 Nov 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients With previously or newly diagnosed cancer With radiologically proven brain metastases
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
- Conditions
- Brain Metastases
- Keywords
- Treatment
- Medical subject headings
- Brain Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival after diagnosis of brain metastases
Calculation of the overall survival times for each patient enrolled
Measured: 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
Description of treatment offered
Measured: 3 years
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.
Measured: Monthly up to 12 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Jan 2018
- Primary completion31 Mar 2022
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Cancer Society, South-Eastern Norway Regional Health Authority
- Responsible party
- Principal investigator, Olav Erich Yri, Oslo University Hospital
- Investigators
- Olav E Yri, MD, Principal investigator, Post-doc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346655
- Sponsor's protocol ID
- 2017/1358
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2017
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Metastases in Norway - Improved Classification and Treatment. A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03346655
- Acronym / sponsor ID
- 2017/1358
- Conditions
- Brain Metastases
- Keywords
- Treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Cancer Society, South-Eastern Norway Regional Health Authority
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients With previously or newly diagnosed cancer With radiologically proven brain metastases
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Treatment offered to patients diagnosed with brain metastases
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olav E Yri, MD principal investigator
Post-doc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Metastases, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.