Using patient-derived organoids to personalize treatment for pancreatic cancer
Pharmacotyping of Patient-derived Pancreatic Cancer Organoids From Endoscopic Ultrasound-guided Biopsy as a Tool for Predicting Oncological Response
This study is testing whether lab-grown mini versions of pancreatic tumors from patients can help doctors find the best chemotherapy for each individual with pancreatic cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 88 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Herlev Hospital Academic / other |
| Locations | 1 site (Herlev, Copenhagen) |
| Trial ID | NCT05196334 on ClinicalTrials.gov |
What this trial studies
This study aims to utilize organoids derived from pancreatic ductal adenocarcinoma (PDAC) patients' tissue samples obtained through endoscopic ultrasound-guided fine needle biopsy (EUS-FNB). The organoids will be cultured and co-cultured with cancer-associated fibroblasts to assess their response to various chemotherapeutic agents. The study will compare the pharmacotyping results of these organoids with the patients' actual treatment responses, providing insights into personalized medicine approaches for pancreatic cancer. The research will be conducted at Herlev Hospital, where patients will undergo standard oncological treatment and evaluation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with histopathologically confirmed pancreatic ductal adenocarcinoma or suspected locally advanced non-metastatic PDAC.
Not a fit: Patients who are not eligible for EUS-FNB or have contraindications for the procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective, personalized treatment strategies for patients with pancreatic cancer.
How similar studies have performed: While the use of organoids in pharmacotyping is a growing field, this specific approach in pancreatic cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Herlev, Copenhagen
- Endoscopy Unit, Herlev Hospital — Herlev, Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Pia H Klausen, PhD — Rigshospitalet, Denmark
- Study coordinator: Pia H Klausen, PhD
- Email: pia.helene.klausen.01@regionh.dk
- Phone: +4535453545
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.