RecruitingNCT05196334
Pharmacotyping of Pancreatic Patient-derived Organoids
Pharmacotyping of Patient-derived Pancreatic Cancer Organoids From Endoscopic Ultrasound-guided Biopsy as a Tool for Predicting Oncological Response
Sponsor
Herlev Hospital
Enrollment
88 participants
Start Date
Jul 1, 2021
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria11
- 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 Criteria2
- Contraindications for nurse administered propofol sedation (NAPS)
- Contraindications for EUS-FNB procedure
Interventions
OTHERNo intervention
No intervention
Locations(1)
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NCT05196334
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