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Pharmacotyping of Patient-derived Pancreatic Cancer Organoids From Endoscopic Ultrasound-guided Biopsy as a Tool for Predicting Oncological Response

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Denmark
Endoscopy Unit, Herlev Hospital
RECRUITING
Herlev
Contact Information
Primary
Pia H Klausen, PhD
pia.helene.klausen.01@regionh.dk
+4535453545
Backup
Simon E Grutzmeier, MD
simon.eban.grutzmeier@regionh.dk
+4538683868
Time Frame
Start Date: 2021-07-01
Estimated Completion Date: 2025-08-31
Participants
Target number of participants: 88
Related Therapeutic Areas
Sponsors
Leads: Herlev Hospital
Collaborators: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov