Actively Recruiting

Age: 18Years +
All Genders
NCT05196334

Pharmacotyping of Pancreatic Patient-derived Organoids

Led by Herlev Hospital · Updated on 2024-10-03

88

Participants Needed

1

Research Sites

217 weeks

Total Duration

On this page

Sponsors

H

Herlev Hospital

Lead Sponsor

R

Rigshospitalet, Denmark

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

Pharmacotyping of Pancreatic Patient-derived Organoids

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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) 23 3 x 109/L
  • Platelet count 23 100 x 109/L
  • Serum bilirubin 1.5 x upper limit of normal (ULN) (patients with Gilbert's Syndrome must have a total bilirubin 1 50 mmol/L)
  • PP 23 40 or INR 1.5
  • Serum creatinine 1.5 x ULN or CrCl 2 40 mL/min (using the Cockcroft-Gault formula)
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Endoscopy Unit, Herlev Hospital

Herlev, Copenhagen, Denmark, 2730

Actively Recruiting

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Research Team

P

Pia H Klausen, PhD

CONTACT

S

Simon E Grutzmeier, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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