Breast CancerUPTIDERNCT04531696
UZ/KU Leuven Program for Post-mortem Tissue Donation to Enhance Research
A study testing Blood draw and Post-mortem tissue collection in people with Breast Cancer and Hereditary Diseases, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Hereditary Diseases
- What is being tested?
- Blood draw and Post-mortem tissue collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Nov 2020to Sep 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Josephine Van Cauwenberge, MD, 0032493364654, josephine.vancauwenberge@kuleuven.be
About this study
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
- Being tested
- Blood draw, Post-mortem tissue collection
- Medical subject headings
- Breast Neoplasms, Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawProcedure or surgery
Blood draw at inclusion
Post-mortem tissue collectionProcedure or surgery
Sample collection (both liquids, tumour tissue and non-tumour tissue) during post-mortem research autopsy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Blood draw; Procedure: Post-mortem tissue collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients consenting to participate in the pilot phase
Should be equal to or above 50%
Measured: Baseline
Median time elapsed between moment of death and start of the autopsy
Should be equal to or less than 12h
Measured: During autopsy
Median time elapsed between collection of first and last sample
Should be equal to or less than 8h
Measured: During autopsy
Percentage of metastatic organs sampled
Should be equal to or more than 75%
Measured: During autopsy
Percentage of samples with sufficient quality of DNA extracted
A260/A280 ratio
Measured: During autopsy
Percentage of samples with sufficient quality of RNA extracted
RNA integrity number (RIN)
Measured: During autopsy
Secondary outcomes (5)
Concordance between TILs and clinical response to treatment
Standard histopathological review
Measured: During autopsy
Rate of T cell exhaustion
RNA sequencing
Measured: During autopsy
Number of mutations in each tumor lesion
Whole exome sequencing
Measured: During autopsy
Type of mutations in each tumor lesion
Whole exome sequencing
Measured: During autopsy
Percentage of Tumour Infiltrating Lymphocytes (TILs)
Standard histopathological review
Measured: During autopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start30 Nov 2020
- Primary completionSep 2035 (estimated)
- Study completionSep 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, Universiteit Antwerpen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531696
- Sponsor's protocol ID
- S64410
- Acronym
- UPTIDER
- Status last verified
- Jun 2024
- First submitted
- 11 Aug 2020
- Last updated
- 28 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UZ/KU Leuven Program for Post-mortem Tissue Donation to Enhance Research
- ClinicalTrials.gov ID
- NCT04531696
- Acronym / sponsor ID
- UPTIDER / S64410
- Conditions
- Breast Cancer, Hereditary Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven, Universiteit Antwerpen
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- Sep 2035 (estimated)
- Study completion
- Sep 2035 (estimated)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard | Other | Procedure: Blood draw, Procedure: Post-mortem tissue collectionUPTIDER 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- ILC substudy: histologically confirmed history of ILC.
Key exclusion criteria (4 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawBlood draw at inclusion | Procedure or surgery | Standard |
| Post-mortem tissue collectionSample collection (both liquids, tumour tissue and non-tumour tissue) during post-mortem research autopsy | Procedure or surgery | Standard |
Primary outcome
Percentage of patients consenting to participate in the pilot phase
Time frame: Baseline
Should be equal to or above 50%
Median time elapsed between moment of death and start of the autopsy
Time frame: During autopsy
Should be equal to or less than 12h
Median time elapsed between collection of first and last sample
Time frame: During autopsy
Should be equal to or less than 8h
Percentage of metastatic organs sampled
Time frame: During autopsy
Should be equal to or more than 75%
Percentage of samples with sufficient quality of DNA extracted
Time frame: During autopsy
A260/A280 ratio
Percentage of samples with sufficient quality of RNA extracted
Time frame: During autopsy
RNA integrity number (RIN)
5 secondary outcomes
Concordance between TILs and clinical response to treatment
Time frame: During autopsy
Rate of T cell exhaustion
Time frame: During autopsy
Number of mutations in each tumor lesion
Time frame: During autopsy
Type of mutations in each tumor lesion
Time frame: During autopsy
Percentage of Tumour Infiltrating Lymphocytes (TILs)
Time frame: During autopsy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood draw and Post-mortem tissue collection in people with Breast Cancer and Hereditary Diseases, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Floris, MD PhD (003216336539, giuseppe.floris@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients consenting to participate in the pilot phase (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.