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

Primary Purpose

Breast Cancer, Hereditary Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Blood draw
Post-mortem tissue collection
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UZ LeuvenRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Standard

Arm Description

UPTIDER consists of 8 substudies: Pilot phase Invasive Lobular Carcinoma (ILC) substudy Inflammatory Breast Cancer (IBC) substudy Molecular heterogeneity and treatment response substudy Patient-derived xenograft (PDX) / Patient-derived Organoid (PDO) substudy Metabolomics substudy Liquid biopsy substudy 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.

Outcomes

Primary Outcome Measures

Percentage of patients consenting to participate in the pilot phase
Should be equal to or above 50%
Median time elapsed between moment of death and start of the autopsy
Should be equal to or less than 12h
Median time elapsed between collection of first and last sample
Should be equal to or less than 8h
Percentage of metastatic organs sampled
Should be equal to or more than 75%
Percentage of samples with sufficient quality of DNA extracted
A260/A280 ratio
Percentage of samples with sufficient quality of RNA extracted
RNA integrity number (RIN)

Secondary Outcome Measures

Concordance between TILs and clinical response to treatment
Standard histopathological review
Rate of T cell exhaustion
RNA sequencing
Number of mutations in each tumor lesion
Whole exome sequencing
Type of mutations in each tumor lesion
Whole exome sequencing
Percentage of Tumour Infiltrating Lymphocytes (TILs)
Standard histopathological review

Full Information

First Posted
August 11, 2020
Last Updated
December 2, 2022
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven, Universiteit Antwerpen
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1. Study Identification

Unique Protocol Identification Number
NCT04531696
Brief Title
UZ/KU Leuven Program for Post-mortem Tissue Donation to Enhance Research
Acronym
UPTIDER
Official Title
UZ/KU Leuven Program for Post-mortem Tissue Donation to Enhance Research
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2020 (Actual)
Primary Completion Date
September 2035 (Anticipated)
Study Completion Date
September 2035 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
KU Leuven, Universiteit Antwerpen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Hereditary Diseases

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
Other
Arm Description
UPTIDER consists of 8 substudies: Pilot phase Invasive Lobular Carcinoma (ILC) substudy Inflammatory Breast Cancer (IBC) substudy Molecular heterogeneity and treatment response substudy Patient-derived xenograft (PDX) / Patient-derived Organoid (PDO) substudy Metabolomics substudy Liquid biopsy substudy 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.
Intervention Type
Procedure
Intervention Name(s)
Blood draw
Intervention Description
Blood draw at inclusion
Intervention Type
Procedure
Intervention Name(s)
Post-mortem tissue collection
Intervention Description
Sample collection (both liquids, tumour tissue and non-tumour tissue) during post-mortem research autopsy
Primary Outcome Measure Information:
Title
Percentage of patients consenting to participate in the pilot phase
Description
Should be equal to or above 50%
Time Frame
Baseline
Title
Median time elapsed between moment of death and start of the autopsy
Description
Should be equal to or less than 12h
Time Frame
During autopsy
Title
Median time elapsed between collection of first and last sample
Description
Should be equal to or less than 8h
Time Frame
During autopsy
Title
Percentage of metastatic organs sampled
Description
Should be equal to or more than 75%
Time Frame
During autopsy
Title
Percentage of samples with sufficient quality of DNA extracted
Description
A260/A280 ratio
Time Frame
During autopsy
Title
Percentage of samples with sufficient quality of RNA extracted
Description
RNA integrity number (RIN)
Time Frame
During autopsy
Secondary Outcome Measure Information:
Title
Concordance between TILs and clinical response to treatment
Description
Standard histopathological review
Time Frame
During autopsy
Title
Rate of T cell exhaustion
Description
RNA sequencing
Time Frame
During autopsy
Title
Number of mutations in each tumor lesion
Description
Whole exome sequencing
Time Frame
During autopsy
Title
Type of mutations in each tumor lesion
Description
Whole exome sequencing
Time Frame
During autopsy
Title
Percentage of Tumour Infiltrating Lymphocytes (TILs)
Description
Standard histopathological review
Time Frame
During autopsy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Floris, MD PhD
Phone
003216336539
Email
giuseppe.floris@uzleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Desmedt, PhD
Phone
003216193306
Ext
www.ltbcr.be
Email
christine.desmedt@kuleuven.be
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josephine Van Cauwenberge, MD
Phone
0032493364654
Email
josephine.vancauwenberge@kuleuven.be

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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