Breast CancerOLiver ProNCT05720676

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.

An observational study of Breast Cancer and Liver Metastases, run by KU Leuven at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer, Liver Metastases
How many people: 20 participants
Where: 1 siteBelgium
Study dates: Mar 2023to Mar 2025
How long will I take part?: 2 Years
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Study population: Breast cancer patients who are planned for liver surgery.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Sophia Leduc
Leuven, 3000
Sophia Leduc, PhD

Other trials in Belgium

About this study

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

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

Participants will be willing and able to provide written informed consent for this study and tissue samples for research purposes.

Conditions: Breast Cancer, Liver Metastases
Medical subject headings: Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2023Mar 2025

First posted9 Feb 2023
Study startMar 2023 (estimated)
Primary completionMar 2025 (estimated)
Study completionMar 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by KU LeuvenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 20 participants (estimated)
Target duration: 2 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT05720676
Sponsor's protocol ID: S-64813
Acronym: OLiver Pro
Status last verified: Jan 2023
First submitted: 31 Jan 2023
Last updated: 9 Feb 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical, Histopathological, Molecular and Experimental Characterization of Liver Metastases From Patients With Breast Cancer.
ClinicalTrials.gov ID: NCT05720676
Acronym / sponsor ID: OLiver Pro / S-64813
Conditions: Breast Cancer, Liver Metastases
Study type: Observational
Recruitment status: Unknown status
Enrolment: 20 participants (estimated)
Lead sponsor: KU LeuvenUniversity, hospital or other
Collaborators: Jules Bordet Institute, Erasme University Hospital, GZA Ziekenhuizen Campus Sint-Augustinus
Study start: Mar 2023 (estimated)
Primary completion: Mar 2025 (estimated)
Study completion: Mar 2025 (estimated)
First posted: 9 Feb 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Participants will be willing and able to provide written informed consent for this study and tissue samples for research purposes.

Study design

Observational model: Case only
Time perspective: Prospective
Target follow-up: 2 Years

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Breast cancer patients who are planned for liver surgery.

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
Individual participant dataSharing planned: Undecided

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Liver Metastases, run by KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To characterize the tumour cells and their microenvironment in the liver metastases at the transcriptomic and protein single-cell level. (time frame: 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05720676.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.