Pharmacotyping of Pancreatic Patient-derived Organoids
Recruiting · NCT05196334 · Observational (researchers observe without assigning treatment) · Lead sponsor: Herlev Hospital
View the official record on ClinicalTrials.gov →Interventions studied
No intervention
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Endoscopy Unit, Herlev Hospital - Herlev, Copenhagen, Denmark