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

NCT04531696 | Recruiting

• 1 other identifier: S64410
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer; Hereditary Diseases

Outcome Measures

Primary Outcomes (6)

• Percentage of patients consenting to participate in the pilot phase

  Should be equal to or above 50%

  Baseline

• Median time elapsed between moment of death and start of the autopsy

  Should be equal to or less than 12h

  During autopsy

• Median time elapsed between collection of first and last sample

  Should be equal to or less than 8h

  During autopsy

• Percentage of metastatic organs sampled

  Should be equal to or more than 75%

  During autopsy

• Percentage of samples with sufficient quality of DNA extracted

  A260/A280 ratio

  During autopsy

• Percentage of samples with sufficient quality of RNA extracted

  RNA integrity number (RIN)

  During autopsy

Secondary Outcomes (5)

• Concordance between TILs and clinical response to treatment

  During autopsy

• Rate of T cell exhaustion

  During autopsy

• Number of mutations in each tumor lesion

  During autopsy

• Type of mutations in each tumor lesion

  During autopsy

• Percentage of Tumour Infiltrating Lymphocytes (TILs)

  During autopsy

Study Arms (1)

Standard

OTHER

UPTIDER consists of 8 substudies: 1. Pilot phase 2. Invasive Lobular Carcinoma (ILC) substudy 3. Inflammatory Breast Cancer (IBC) substudy 4. Molecular heterogeneity and treatment response substudy 5. Patient-derived xenograft (PDX) / Patient-derived Organoid (PDO) substudy 6. Metabolomics substudy 7. Liquid biopsy substudy 8. Hereditary cancer syndromes substudy The intervention, consisting of sample collection only, is identical in all substudies, however, the focus of downstream analysis of the samples may be different.

Procedure: Blood draw; Procedure: Post-mortem tissue collection

Interventions

Blood draw PROCEDURE

Blood draw at inclusion

Standard

Post-mortem tissue collection PROCEDURE

Sample collection (both liquids, tumour tissue and non-tumour tissue) during post-mortem research autopsy

Standard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• KU Leuven: collaborator
• Universiteit Antwerpen: collaborator

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Genetic Diseases, Inborn

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Giuseppe Floris, MD PhD

CONTACT

003216336539; giuseppe.floris@uzleuven.be

Christine Desmedt, PhD

CONTACT

003216193306; christine.desmedt@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 28, 2020
• Study Start: November 30, 2020
• Primary Completion (Estimated): September 1, 2035
• Study Completion (Estimated): September 1, 2035
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

BE (1)