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.

Breast Cancer Clinical Trial

— OLiver Pro  

Official title:

Clinical, Histopathological, Molecular and Experimental Characterization of Liver Metastases From Patients With Breast Cancer.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05720676
• Other study ID #: S-64813
• Status: Not yet recruiting
• Start date: March 2023
• Est. completion date: March 2025

Study information

• Verified date: January 2023
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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: 1. To characterize the tumour cells and their microenvironment in the liver metastases at the transcriptomic and protein single-cell level; 2. To determine the levels and patterns of immune infiltrates in liver metastases from BC patients; 3. To identify biological features associated with the histopathological growth patterns in liver metastases. 4. To create patient-derived xenografts (PDX) and organoids (PDO) from liver metastases isolated from patients with BC; 5. To perform a histopathological and molecular comparison of liver metastases, PDX and PDO isolated from the same patient Participants will be willing and able to provide written informed consent for this study and tissue samples for research purposes.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

Locations

Country	Name	City	State
Belgium	Sophia Leduc	Leuven

Sponsors (4)

Lead Sponsor	Collaborator
KU Leuven	Erasme University Hospital, GZA Ziekenhuizen Campus Sint-Augustinus, Jules Bordet Institute

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize the tumour cells and their microenvironment in the liver metastases at the transcriptomic and protein single-cell level.		2 years
Primary	To determine the levels and patterns of immune infiltrates in liver metastases from BC patients		2 years
Primary	To identify biological features associated with the histopathological growth patterns in liver metastases.		2 years
Primary	To create patient-derived xenografts (PDX) and organoids (PDO) from liver metastases isolated from patients with BC		2 years
Primary	To perform a histopathological and molecular comparison of liver metastases, PDX and PDO isolated from the same patient.		2 years
Primary	To investigate the histopathological growth patterns of liver metastases using intra-vital imaging of these metastases in PDX.		2 years
Primary	To use PDX and PDO to evaluate the efficacy of various treatments.		2 years