NCT05196334 Pharmacotyping of Pancreatic Patient-derived Organoids
| NCT ID | NCT05196334 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Herlev Hospital |
| Condition | Pancreatic Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 88 participants |
| Start Date | 2021-07-01 |
| Primary Completion | 2025-08-30 |
Trial Parameters
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Brief Summary
EUS-FNB samples will be used for organoid cultures, which will be co-cultured with cancer associated fibroblasts derived from the surrounding stroma of the lesion. The organoid cultures will be used for pharmacotyping using relevant chemotherapeutic agents used in the clinic, and the organoid's response compared with the patient's response.
Eligibility Criteria
Inclusion Criteria: * Signed informed consent * Histopathological confirmation of PDAC and planned standard first-line treatment prior to entering this study OR Patients suspected of primary locally advanced, non-metastatic PDAC based on cross-sectional imaging undergoing diagnostic standard of care (SOC) EUS-FNB procedure * Age \> 18 years and older * Life expectancy greater than 3 months * ECOG/WHO Performance Status (PS) 0-1 * Patients must have normal organ and marrow function as defined below: * White blood cell count (WBC) ≥ 3 x 10⁹/L * Platelet count ≥ 100 x 10⁹/L * Serum bilirubin ≤1.5 x upper limit of normal (ULN) (patients with Gilbert's Syndrome must have a total bilirubin ≤ 50 mmol/L) * PP ≥ 40 or INR ≤ 1.5 * Serum creatinine ≤ 1.5 x ULN or CrCl ≥ 40 mL/min (using the Cockcroft-Gault formula) Exclusion Criteria: * Contraindications for nurse administered propofol sedation (NAPS) * Contraindications for EUS-FNB procedure
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