Post-mortem tissue donation program for breast cancer research
UZ/KU Leuven Program for Post-mortem Tissue Donation to Enhance Research
This program is collecting tissue samples from patients with metastatic breast cancer to help researchers learn more about how the cancer develops and why some treatments don’t work.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT04531696 on ClinicalTrials.gov |
What this trial studies
This program focuses on collecting post-mortem tissue samples from patients with metastatic breast cancer or hereditary cancer syndromes to enhance understanding of cancer evolution, biology, and treatment resistance. It involves extensive analysis of multi-level and multi-region samples to assess tumor biology and pathogenicity. The program is designed for patients treated at UZ Leuven or referred from other hospitals, ensuring a comprehensive approach to studying these conditions.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with metastatic breast cancer or hereditary cancer syndromes associated with a high lifetime risk of breast cancer.
Not a fit: Patients without a diagnosis of metastatic breast cancer or hereditary cancer syndromes may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly advance the understanding of breast cancer and hereditary cancer syndromes, leading to improved treatment strategies.
How similar studies have performed: While similar approaches have been explored, this specific program is novel in its comprehensive post-mortem analysis for these particular conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years. * Signature of informed consent by the subject. * Metastatic breast cancer, or hereditary cancer syndrome with a moderate to high lifetime risk of breast cancer, for which the patient is treated/followed in UZ Leuven or treated in another hospital and referred to UZ Leuven specifically for the trial. Additional inclusion criteria for the different substudies: * Pilot phase: no additional inclusion criteria. * ILC substudy: histologically confirmed history of ILC. * IBC substudy: history of IBC, fulfilling the following criteria described by Dawood et al: rapid onset of breast erythema, oedema and/or peau d'orange and/or warm breast with or without an underlying palpable mass, duration of history of no more than 6 months, erythema occupying at least one-third of the breast and pathological confirmation of invasive carcinoma. * Hereditary cancer syndrome substudy: confirmed presence of a germline mutation known to be associated with a moderate to high lifetime risk of BC (e.g. known pathogenic variants in the genes BRCA1/2, CHEK2, TP53, PALB2) and presence of at least one malignant lesion at time of inclusion (of any origin) . * Other substudies: no additional inclusion criteria. Exclusion Criteria: * Presence of a transmissible disease that can form a risk to the health of researchers or others handling the body or patient samples. This includes but is not limited to the following infectious diseases: human immunodeficiency virus (HIV), active hepatitis C virus (HCV), encephalitis of unknown cause, Creutzfeldt-Jakob disease, rabies, active malaria, active tuberculosis, active SARS-CoV-2 infection. * Presence of any factors that could logistically or organizationally impede the study or the performance of sampling within a reasonable post-mortem time frame. This includes but is not limited to: residence of the subject at a faraway distance from the UZ Leuven hospital; residence of the subject on territory outside of Belgium; impossibility to notify the clinician confirming the death and the researchers within a reasonable time frame in case of death. Additional exclusion criteria for the different substudies: \- ILC substudy, IBC substudy: diagnosis of a malignancy other than breast cancer in the 5 years prior to inclusion. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin and in situ cervical carcinoma.
Where this trial is running
Leuven
- UZ Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Study coordinator: Giuseppe Floris, MD PhD
- Email: giuseppe.floris@uzleuven.be
- Phone: 003216336539
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.