Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05720676
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-09
First Post:
2023-01-31
Brief 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
Sponsor:
KU Leuven
Organization:
KU Leuven
Study Overview
Official Title:
Clinical Histopathological Molecular and Experimental Characterization of Liver Metastases From Patients With Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OLiver Pro
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
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None