Primary objective:To establish and propagate a bladder cancer / immune cell co-culture model to study patient response to immunotherapy ex vivo. (Can organoid and immune cell co-cultures be maintained for 3 passages?) Protocols will be improved…
ID
Source
Brief title
Condition
- Renal and urinary tract neoplasms malignant and unspecified
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- If we can use the near-patient organoid model to predict response to treatment
- If the organoid immune microenvironment changes in relation to drug treatment
Secondary outcome
Not applicable.
Background summary
Contrary to cell lines and FFPE material, organoids have been shown to
represent a patient-specific primary culture system that remains genetically
stable, that can indefinitely be expanded and that provides a platform to study
tumor biology and serves as a near-patient platform for drug sensitivity
testing. We currently have the *Generation of bladder cancer tumoroids for drug
sensitivity protocol (MEC-2018-1096)* running at the Erasmus MC Bladder Cancer
Center. With novel immunotherapy treatment options becoming available for
bladder cancer (BC), investigation of the tumor immune environment has become a
major subject of investigation. Hence, this protocol has a novel addition of
the organoid immune co-culture system.
Study objective
Primary objective:
To establish and propagate a bladder cancer / immune cell co-culture model to
study patient response to immunotherapy ex vivo. (Can organoid and immune cell
co-cultures be maintained for 3 passages?) Protocols will be improved until we
achieve a success rate of 75% of higher.
Secondary objectives:
1. To investigate whether organoids mimic drug sensitivity from the clinical
setting (can we use organoids to predict response to currently used treatments?)
2. How does the tumor immune environment respond to treatment in the organoid
model and is this related to treatment response?
Study design
Patients with both non-muscle and muscle-invasive BC, who are selected for
surgical resection of the tumor are approached for participation. Tissue
(normal and tumor) will be collected for organoid culturing. Additionally,
collection of blood (cells, serum and plasma) and urine will be performed at
different time-points (pre-during-after treatment) to setup organoid
co-cultures. Clinical data is collected through Erasmus MC dashboards for each
specific type of BC. Collection is prospective and it is anticipated that
sample collection will be a continuous process for which no end date is
specified. Outcome will be defined by the specific response of the immune
environment to different drugs.
Study burden and risks
Blood will be drawn before, during and after treatment. All blood draws will be
performed during a blood draw already required for standard of care.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
• Age >= 18 years at time of inclusion
• Written informed consent
• Able to read and understand the patient information
• Mentally and physically able to participate according to the treating
physician.
Exclusion criteria
• Known HIV-infection or other serious infectious disease which can be
transferred by one of the biomaterials.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL78597.078.21 |