To hear about similar clinical trials, please enter your email below
Trial Title:
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.
NCT ID:
NCT05720676
Condition:
Breast Cancer
Liver Metastases
Conditions: Official terms:
Breast Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Study type:
Observational [Patient Registry]
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Breast cancer patients who are planned for liver surgery.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sophia Leduc
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Contact:
Last name:
Sophia Leduc, PhD
Start date:
March 2023
Completion date:
March 2025
Lead sponsor:
Agency:
KU Leuven
Agency class:
Other
Collaborator:
Agency:
Jules Bordet Institute
Agency class:
Other
Collaborator:
Agency:
Erasme University Hospital
Agency class:
Other
Collaborator:
Agency:
GZA Ziekenhuizen Campus Sint-Augustinus
Agency class:
Other
Source:
KU Leuven
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05720676
