UZ/KU Leuven Program for Post-mortem Tissue Donation to Enhance Research
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood draw, Post-mortem tissue collection.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Hereditary Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
UPTIDER is a prospective, interventional, non-Investigational Medicinal Product (non-IMP), non-commercial, single centre post-mortem tissue donation program for metastatic breast cancer patients or patients with a germline pathogenic variant with a moderate to high lifetime risk of breast cancer and at least one malignancy at time of death. The overarching objective of UPTIDER is (i) to unravel metastatic breast cancer evolution, biology, heterogeneity and treatment resistance and (ii) to assess pathogenicity and tumour biology in hereditary cancer syndromes with a high lifetime risk of breast cancer; both through extensive post-mortem multi-level and multi-region sample analysis.
Interventions
- Procedure Blood draw
Blood draw at inclusion - Procedure Post-mortem tissue collection
Sample collection (both liquids, tumour tissue and non-tumour tissue) during post-mortem research autopsy
Primary outcome measures
- Percentage of patients consenting to participate in the pilot phase [Time frame: Baseline]
- Median time elapsed between moment of death and start of the autopsy [Time frame: During autopsy]
- Median time elapsed between collection of first and last sample [Time frame: During autopsy]
- Percentage of metastatic organs sampled [Time frame: During autopsy]
- Percentage of samples with sufficient quality of DNA extracted [Time frame: During autopsy]
- Percentage of samples with sufficient quality of RNA extracted [Time frame: During autopsy]
Secondary outcome measures (5)
- Concordance between TILs and clinical response to treatment [Time frame: During autopsy]
- Rate of T cell exhaustion [Time frame: During autopsy]
- Number of mutations in each tumor lesion [Time frame: During autopsy]
- Type of mutations in each tumor lesion [Time frame: During autopsy]
- Percentage of Tumour Infiltrating Lymphocytes (TILs) [Time frame: During autopsy]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Belgium · 1 center
- UZ Leuven — Leuven
Identifiers
NCT: NCT04531696 · S64410