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

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ClinicalTrials.gov Identifier: NCT04531696
Recruitment Status : Recruiting
First Posted : August 28, 2020
Last Update Posted : April 1, 2021
Sponsor:
Collaborators:
KU Leuven
Universiteit Antwerpen
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Hereditary Diseases Procedure: Blood draw Procedure: Post-mortem tissue collection Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: UZ/KU Leuven Program for Post-mortem Tissue Donation to Enhance Research
Actual Study Start Date : November 30, 2020
Estimated Primary Completion Date : September 2035
Estimated Study Completion Date : September 2035

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Standard

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
Blood draw at inclusion

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


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of patients consenting to participate in the pilot phase [ Time Frame: Baseline ]
    Should be equal to or above 50%

  2. Median time elapsed between moment of death and start of the autopsy [ Time Frame: During autopsy ]
    Should be equal to or less than 12h

  3. Median time elapsed between collection of first and last sample [ Time Frame: During autopsy ]
    Should be equal to or less than 8h

  4. Percentage of metastatic organs sampled [ Time Frame: During autopsy ]
    Should be equal to or more than 75%

  5. Percentage of samples with sufficient quality of DNA extracted [ Time Frame: During autopsy ]
    A260/A280 ratio

  6. Percentage of samples with sufficient quality of RNA extracted [ Time Frame: During autopsy ]
    RNA integrity number (RIN)


Secondary Outcome Measures :
  1. Concordance between TILs and clinical response to treatment [ Time Frame: During autopsy ]
    Standard histopathological review

  2. Rate of T cell exhaustion [ Time Frame: During autopsy ]
    RNA sequencing

  3. Number of mutations in each tumor lesion [ Time Frame: During autopsy ]
    Whole exome sequencing

  4. Type of mutations in each tumor lesion [ Time Frame: During autopsy ]
    Whole exome sequencing

  5. Percentage of Tumour Infiltrating Lymphocytes (TILs) [ Time Frame: During autopsy ]
    Standard histopathological review


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04531696


Contacts
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Contact: Giuseppe Floris, MD PhD 003216336539 giuseppe.floris@uzleuven.be
Contact: Christine Desmedt, PhD 003216193306 christine.desmedt@kuleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Tatjana Geukens, MD    0032475269508    tatjana.geukens@kuleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
KU Leuven
Universiteit Antwerpen
More Information
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT04531696    
Other Study ID Numbers: S64410
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Genetic Diseases, Inborn