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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Measurement of organoid's response to therapy — Organoid co-cultures will be established and pharmacotyped in a timeframe of 2-4 weeks. Response of patient derived organoids to standard chemotherapeutic agents used for treatment of patients with pancreatic cancer
Validation of patient's response to therapy — 3 months follow up Computed tomography (CT) scan of the thorax and abdomen are performed at baseline (within 28 days prior to first study drug administration) to assess efficacy of the drugs in patients.
Comparison between organoid's and patient's response — 4 months The response measured in the pharmacoscreen of organoids will be compared with the patient's response
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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