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)

Endoscopy Unit, Herlev Hospital

Herlev, Copenhagen, Denmark

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NCT05196334


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