Urigenital cancer
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients with metastasized bladder cancer or prostate cancer
Exclusion criteria
Exclusion criteria: - Comorbidity that interferes with the safe removal of extra tissue. - Objection against anonymized storage of tissue for an unlimited period of time. - Objection against disclosure of relevant incidental findings (DNA sequencing).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Percentage of organoid cultures with >2 passages and percentage of organoid-lines (>4 passages). - Percentage of organoids in which the DNA profile shows strong concordance with the DNA profile of biopsy tissue (>70% concordance regarding aberrations of snvs/InDels/CNVs) - Therapies for which a factor 3 difference in cell viability is found between organoids with and organoids without aberrations in the targeted pathway. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundaire outcome measures: - Percentage of organoid-lines per used culture medium - Percentage of druggable aberrations in organoids - Percentage of lymfocyte-organoid cocultures in which after 2 weeks an increase in T cell activity is measured (INF-* ELISPOT) Exploratory - Concordance between organoids and biopsy tissue regarding immunological landscape (variables: lymfocyte/tumor cell ratio, density T cell subsets, expression of checkpoint molecules). - Relation between immunological landscape and overall and progression-free survival (Cox-proportional hazard analyse) (variables: lymfocyte/tumor cell ratio, density T cell subsets, cytokine profile; expression of checkpoint molecules) - Impact of the above mentioned variables on response according to RECIST1.1 (CR/PR vs SD/PD) and drug-sensitivity analysis in organoids (>30% vs | — |
Countries
Netherlands
Outcome results
None listed