UZ/KU Leuven Program for Post-mortem Tissue Donation to Enhance Research
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Pilot phase: no additional inclusion criteria.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Blood draw
Procedure/SurgeryBlood draw at inclusion
Post-mortem tissue collection
Procedure/SurgerySample collection (both liquids, tumour tissue and non-tumour tissue) during post-mortem research autopsy
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: StandardOther 2 interventions
Trial outcomes
Primary outcomes
1
Percentage of patients consenting to participate in the pilot phase
Should be equal to or above 50%
Time frame
Baseline2
Median time elapsed between moment of death and start of the autopsy
Should be equal to or less than 12h
Time frame
During autopsy3
Median time elapsed between collection of first and last sample
Should be equal to or less than 8h
Time frame
During autopsy4
Percentage of metastatic organs sampled
Should be equal to or more than 75%
Time frame
During autopsySecondary outcomes
1
Concordance between TILs and clinical response to treatment
Standard histopathological review
Time frame
During autopsy2
Rate of T cell exhaustion
RNA sequencing
Time frame
During autopsy3
Number of mutations in each tumor lesion
Whole exome sequencing
Time frame
During autopsy4
Type of mutations in each tumor lesion
Whole exome sequencing
Time frame
During autopsySponsors and contacts
Click on the lead sponsor to view all of their trials.
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
KU Leuven
Collaborator
Universiteit Antwerpen
Collaborator
Source ClinicalTrials.gov