Clinical, Histological and In-depth Molecular Characterization as Well as Experimental Models of Liver Metastasis From Patients With Breast Cancer in Order to Identify New Potential Treatment Avenues.
OLiver Pro
Clinical, Histopathological, Molecular and Experimental Characterization of Liver Metastases From Patients With Breast Cancer.
1 other identifier
observational
20
1 country
1
Brief Summary
The goal of this observational study is to learn about breast cancer liver metastasis in patients who met the following criteria:
- female;
- be ≥ 18 years of age on the day of signing informed consent;
- confirmed diagnosis of breast cancer liver metastases. Newly diagnosed patients with de-novo liver metastases are eligible;
- be planned for liver surgery. The main questions it aims to answer are:
- To characterize the tumour cells and their microenvironment in the liver metastases at the transcriptomic and protein single-cell level;
- To determine the levels and patterns of immune infiltrates in liver metastases from BC patients;
- To identify biological features associated with the histopathological growth patterns in liver metastases.
- To create patient-derived xenografts (PDX) and organoids (PDO) from liver metastases isolated from patients with BC;
- To perform a histopathological and molecular comparison of liver metastases, PDX and PDO isolated from the same patient
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2023
CompletedFirst Posted
Study publicly available on registry
February 9, 2023
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedFebruary 9, 2023
January 1, 2023
2 years
January 31, 2023
January 31, 2023
Conditions
Outcome Measures
Primary Outcomes (7)
To characterize the tumour cells and their microenvironment in the liver metastases at the transcriptomic and protein single-cell level.
2 years
To determine the levels and patterns of immune infiltrates in liver metastases from BC patients
2 years
To identify biological features associated with the histopathological growth patterns in liver metastases.
2 years
To create patient-derived xenografts (PDX) and organoids (PDO) from liver metastases isolated from patients with BC
2 years
To perform a histopathological and molecular comparison of liver metastases, PDX and PDO isolated from the same patient.
2 years
To investigate the histopathological growth patterns of liver metastases using intra-vital imaging of these metastases in PDX.
2 years
To use PDX and PDO to evaluate the efficacy of various treatments.
2 years
Eligibility Criteria
Breast cancer patients who are planned for liver surgery.
You may qualify if:
- be willing and able to provide written informed consent for this study;
- female;
- be ≥ 18 years of age on the day of signing informed consent;
- confirmed diagnosis of breast cancer liver metastases. Newly diagnosed patients with de-novo liver metastases are eligible;
- be planned for liver surgery;
- be willing to provide tissue samples for research purposes.
You may not qualify if:
- unwillingness to provide the samples or clinical information needed for the study;
- History of radiofrequency destruction (RF), stereotactic Body Radiotherapy (SBRT) or intra-arterial treatment such as chemoembolization (TACE) or selective internal radiation therapy (SIRT) performed on the metastasis to be examined (accepted if performed in other metastasis);
- Has an active autoimmune disease that has required systemic treatment in the past 2 years prior to the surgery (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment;
- Presence of immunodeficiency or immune dysregulatory diseases and conditions which require active immune modulatory treatment of any kind, or required treatment in the past two years from date of diagnosis of breast cancer;
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results in the opinion of the treating investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KU Leuvenlead
- Jules Bordet Institutecollaborator
- Erasme University Hospitalcollaborator
- GZA Ziekenhuizen Campus Sint-Augustinuscollaborator
Study Sites (1)
Sophia Leduc
Leuven, 3000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Student
Study Record Dates
First Submitted
January 31, 2023
First Posted
February 9, 2023
Study Start
March 1, 2023
Primary Completion
March 1, 2025
Study Completion
March 1, 2025
Last Updated
February 9, 2023
Record last verified: 2023-01