Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04531696

UZ/KU Leuven Program for Post-mortem Tissue Donation to Enhance Research

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-06-28

100

Participants Needed

1

Research Sites

769 weeks

Total Duration

On this page

Sponsors

U

Universitaire Ziekenhuizen KU Leuven

Lead Sponsor

K

KU Leuven

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

UZ/KU Leuven Program for Post-mortem Tissue Donation to Enhance Research

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 6 18 years
  • Signed informed consent
  • Diagnosis of metastatic breast cancer or hereditary cancer syndrome with moderate to high lifetime breast cancer risk, treated or followed at UZ Leuven or referred there for the trial
  • For the pilot phase: no additional criteria
  • For the ILC substudy: histologically confirmed invasive lobular carcinoma
  • For the IBC substudy: history of inflammatory breast cancer with rapid onset symptoms and pathological confirmation
  • For hereditary cancer syndrome substudy: confirmed germline mutation linked to moderate/high breast cancer risk and at least one malignant lesion at inclusion
  • For other substudies: no additional criteria
Not Eligible

You will not qualify if you...

  • Presence of transmissible diseases that risk health of researchers or handlers, including HIV, active hepatitis C, unknown encephalitis, Creutzfeldt-Jakob disease, rabies, active malaria, active tuberculosis, or active SARS-CoV-2 infection
  • Factors impeding study logistics or sampling within reasonable post-mortem time, including living far from UZ Leuven or outside Belgium, or inability to notify clinicians/researchers promptly after death
  • For ILC and IBC substudies: diagnosis of another malignancy within 5 years before inclusion, except basal cell or squamous cell skin carcinoma and in situ cervical carcinoma

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

UZ Leuven

Leuven, Belgium, 3000

Actively Recruiting

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Research Team

G

Giuseppe Floris, MD PhD

CONTACT

C

Christine Desmedt, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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UZ/KU Leuven Program for Post-mortem Tissue Donation to Enhance Research | DecenTrialz