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Status unknownNCT05185557Updated Feb 3, 2023

BRIANSTORM - Early Identification of Patients With Brain Metastases

An observational study in Metastatic Rectal Adenocarcinoma and Brain Metastases, sponsored by Aarhus University Hospital. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-03.

Sponsored by Aarhus University Hospital · Observational

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
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Study summary

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

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Conditions studied

  • Metastatic Rectal Adenocarcinoma
  • Brain Metastases
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In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's planned enrollment of 50 is below the median of 121 across 594 observational studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

Aarhus University Hospital is the lead sponsor of 289 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

The study population consists of patients with metastatic rectal cancer and presence of lung metastasis.

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

Exclusion Criteria:

  • Contraindications for MRI Priorly treated or known brain metastases
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Incidence of brain metastasis

    Incidence of brain metastasis in a high risk selected group

    Time frame: 2 years

Secondary outcomes

  1. Number of brain metastases eligible for local treatment options

    Number of brain metastases eligible for local treatment options

    Time frame: 2 years

  2. Median two year overall survival

    Median two year overall survival

    Time frame: 2 years last patient

  3. Prognostic value of circulating DNA levels at baseline

    Time frame: 2 years last patient

  4. Descriptive biological analysis of tumor tissue and circulating tumor DNA

    Time frame: 2 years last patient

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Study locations

1 site
  • Department of Oncology, Aarhus University Hospital
    Aarhus N, 8200, Denmark
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05185557
Lead sponsor
Aarhus University Hospital
Responsible party
Anders Kindberg Boysen (MD, PhD, Aarhus University Hospital) — Principal investigator
First posted
Jan 11, 2022
Start date
Aug 16, 2021
Primary completion
Aug 2023 (estimated)
Completion
Feb 2025 (estimated)
Last update
Feb 3, 2023

Study contacts

Anders K Boysen, MD, PhD
principal investigator · Department of Oncology, Aarhus University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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