Metastatic Rectal AdenocarcinomaNCT05185557
BRIANSTORM - Early Identification of Patients With Brain Metastases
An observational study of Metastatic Rectal Adenocarcinoma and Brain Metastases, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
A single arm observational study investigating the incidence of brain metastasis in patients with cancer recti and lung metastasis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Rectal Adenocarcinoma, Brain Metastases
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Aug 2021to Feb 2025
- 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
- Adult, Older adult
Study population: The study population consists of patients with metastatic rectal cancer and presence of lung metastasis.
Who may be able to join
- Primary rectal tumor location
- Diagnosis of lung metastasis made by histo- or cytopathology, or by clinical and imaging criteria.
- Able to understand written information
- Consent to samples for translational research
Who cannot join
- Contraindications for MRI Priorly treated or known brain metastases
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Oncology, Aarhus University Hospital
Aarhus N, 8200
About this study
A single arm observational study investigating the incidence of brain metastasis in patients with cancer recti and lung metastasis
Read the detailed description
In this study the investigators want to investigate the incidence of brain metastasis in a selected high-risk group of patients with metastatic colorectal cancer. Possible prognostic biological aspects will be investigated by translational analysis of biological samples. The study population consists of patients with metastatic rectal cancer and presence of lung metastasis. The patients will undergo a standard MRI scan of the brain including injection of intravenous contrast. If positive finding, images will be evaluated at the multidisciplinary tumor board for potential treatment options according to clinical practice. Standard follow-up program is followed, as per clinical practice. If the initial MRI scan of cerebrum detects brain metastasis this will be treated and followed as per clinical practice. Translational blood samples will be drawn at inclusion and at every imaging schedule up til 5 times
- Conditions
- Metastatic Rectal Adenocarcinoma, Brain Metastases
- Medical subject headings
- Rectal Neoplasms, Brain Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of brain metastasis
Incidence of brain metastasis in a high risk selected group
Measured: 2 years
Secondary outcomes (4)
Number of brain metastases eligible for local treatment options
Number of brain metastases eligible for local treatment options
Measured: 2 years
Median two year overall survival
Median two year overall survival
Measured: 2 years last patient
Prognostic value of circulating DNA levels at baseline
Measured: 2 years last patient
Descriptive biological analysis of tumor tissue and circulating tumor DNA
Measured: 2 years last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start16 Aug 2021
- Primary completionAug 2023 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Rectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Aarhus 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Kindberg Boysen, Aarhus University Hospital
- Investigators
- Anders K Boysen, MD, PhD, Principal investigator, Department of Oncology, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05185557
- Sponsor's protocol ID
- 1-10-72-269-20
- Status last verified
- Feb 2023
- First submitted
- 16 Dec 2021
- Last updated
- 3 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRIANSTORM - Early Identification of Patients With Brain Metastases
- ClinicalTrials.gov ID
- NCT05185557
- Acronym / sponsor ID
- 1-10-72-269-20
- Conditions
- Metastatic Rectal Adenocarcinoma, Brain Metastases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 11 Jan 2022 (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.
A single arm observational study investigating the incidence of brain metastasis in patients with cancer recti and lung metastasis
Detailed description
In this study the investigators want to investigate the incidence of brain metastasis in a selected high-risk group of patients with metastatic colorectal cancer. Possible prognostic biological aspects will be investigated by translational analysis of biological samples. The study population consists of patients with metastatic rectal cancer and presence of lung metastasis. The patients will undergo a standard MRI scan of the brain including injection of intravenous contrast. If positive finding, images will be evaluated at the multidisciplinary tumor board for potential treatment options according to clinical practice. Standard follow-up program is followed, as per clinical practice. If the initial MRI scan of cerebrum detects brain metastasis this will be treated and followed as per clinical practice. Translational blood samples will be drawn at inclusion and at every imaging schedule up til 5 times
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients with metastatic rectal cancer and presence of lung metastasis.
Key inclusion criteria (4 listed)
- Primary rectal tumor location
Key exclusion criteria (1 listed)
- Contraindications for MRI Priorly treated or known brain metastases
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
Incidence of brain metastasis
Time frame: 2 years
Incidence of brain metastasis in a high risk selected group
4 secondary outcomes
Number of brain metastases eligible for local treatment options
Time frame: 2 years
Median two year overall survival
Time frame: 2 years last patient
Prognostic value of circulating DNA levels at baseline
Time frame: 2 years last patient
Descriptive biological analysis of tumor tissue and circulating tumor DNA
Time frame: 2 years last patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
Related trials for Metastatic Rectal Adenocarcinoma
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1
A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors
Metastatic Solid Tumors
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 1/2
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
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.
Anders K Boysen, MD, PhD principal investigator
Department of Oncology, Aarhus University Hospital
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 Metastatic Rectal Adenocarcinoma and Brain Metastases, run by Aarhus University Hospital at 1 site in Denmark.
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 4 inclusion and 1 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 Feb 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 Denmark. 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?
Incidence of brain metastasis (time frame: 2 years). 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 Feb 2023.