Status:
RECRUITING
Pharmacotyping of Pancreatic Patient-derived Organoids
Lead Sponsor:
Herlev Hospital
Collaborating Sponsors:
Rigshospitalet, Denmark
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
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 f...
Detailed Description
Aim: To use organoids cultured from diagnostic endoscopic ultrasound (EUS)-guided fine needle biopsy (FNB) samples from patients with pancreatic ductal adenocarcinoma (PDAC) for pharmacotyping. Patie...
Eligibility Criteria
Inclusion
- 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
- Contraindications for nurse administered propofol sedation (NAPS)
- Contraindications for EUS-FNB procedure
Key Trial Info
Start Date :
July 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT05196334
Start Date
July 1 2021
End Date
August 31 2025
Last Update
October 3 2024
Active Locations (1)
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1
Endoscopy Unit, Herlev Hospital
Herlev, Copenhagen, Denmark, 2730