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BRIANSTORM - Early Identification of Patients With Brain Metastases

BRIANSTORM - Early Identification of Patients With Brain Metastases

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05185557
Enrollment
50
Registered
2022-01-11
Start date
2021-08-16
Completion date
2025-02-28
Last updated
2023-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Metastases, Metastatic Rectal Adenocarcinoma

Brief summary

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

Interventions

None listed

Sponsors

Aarhus University Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* 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

Exclusion criteria

* Contraindications for MRI Priorly treated or known brain metastases

Design outcomes

Primary

MeasureTime frameDescription
Incidence of brain metastasis2 yearsIncidence of brain metastasis in a high risk selected group

Secondary

MeasureTime frameDescription
Number of brain metastases eligible for local treatment options2 yearsNumber of brain metastases eligible for local treatment options
Median two year overall survival2 years last patientMedian two year overall survival
Prognostic value of circulating DNA levels at baseline2 years last patient
Descriptive biological analysis of tumor tissue and circulating tumor DNA2 years last patient

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026