Pharmacotyping of Pancreatic Patient-derived Organoids

Recruiting now

Conditions studied: Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT05196334

Run by

Herlev Hospital

People needed

88

Starts

2021-07-01

Expected to finish

2025-08-31

Last updated by the study team

2024-10-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• Contraindications for nurse administered propofol sedation (NAPS)
• Contraindications for EUS-FNB procedure

Where it is running

• Endoscopy Unit, Herlev Hospital — Herlev, Copenhagen, Denmark (enrolling)

Full record on ClinicalTrials.gov

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