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NCT05185557 Clinical Trial

BRIANSTORM - Early Identification of Patients With Brain Metastases

Brain Metastases Clinical Trial

Official title:
BRIANSTORM - Early Identification of Patients With Brain Metastases

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05185557
Other study ID # 1-10-72-269-20
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 16, 2021
Est. completion date February 2025

Study information
Verified date February 2023
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A single arm observational study investigating the incidence of brain metastasis in patients with cancer recti and lung metastasis

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 50
Est. completion date February 2025
Est. primary completion date August 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Department of Oncology, Aarhus University Hospital Aarhus N

Sponsors (1)
Lead Sponsor Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of brain metastasis Incidence of brain metastasis in a high risk selected group 2 years
Secondary Number of brain metastases eligible for local treatment options Number of brain metastases eligible for local treatment options 2 years
Secondary Median two year overall survival Median two year overall survival 2 years last patient
Secondary Prognostic value of circulating DNA levels at baseline 2 years last patient
Secondary Descriptive biological analysis of tumor tissue and circulating tumor DNA 2 years last patient
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