NCT05351983Completed
Patient-derived Organoids Drug Screen in Pancreatic Cancer
Patient-derived Organoid Generation in Pancreatic Cancer: a Single Centre, Open-label, Single Arm Feasibility Study
Source: ClinicalTrials.gov · Last updated 25 Sept 2025
Brief summary (registry, in English)
Few chemotherapeutic options exist for pancreatic cancer. Moreover, objective criteria are lacking for deciding which regimen is more beneficial for patient presenting with metastases at diagnosis. This study investigates whether organoid generation from tumour samples of pancreatic cancer is a safe and feasible process for testing of multiple chemotherapy regimens in the laboratory. By participating to this study, patients will have a part of the tumour tissue retrieved and sent to the laboratory for organoid generation and drug testing. For surgically-resectable tumors, tumoral tissue samples will be collected from the main surgical specimens, before sending it for final pathological examination. In case of suspected metastatic lesion at diagnosis, curative surgery is not indicated. Therefore, we will offer patients to undergo port-a-cath implantation for chemotherapy delivery and concomitant laparoscopic surgical excisional biopsy of suspicious metastatic (either hepatic or peritoneal) lesions. At this stage of the study, the treatment that the patient will receive after surgery will not be affected by the results of the laboratory testing. In fact, all patients will receive the standard of care treatment based on the most recent oncologic guidelines and on the oncologist's clinical judgement. As part of the study, each patient will be followed for 30 days to assess possible surgical complications related to the surgical biopsy. This study will help to speed up the implementation of organoid generation in the clinical routine for the choice of the best treatment of patients affected by pancreatic cancer.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 1 Apr 2022
- Start date
- 22 Sept 2022
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Prof. Dr. med. Dres. h.c. Jan Schmidt, MME
- Diseases
- Pancreatic cancer
- NCT number
- NCT05351983
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 22 Sept 2022 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant need for full anticoagulation that cannot be interrupted or bridged prior to tissue biopsy
- Severe or uncontrolled concurrent illness
- Myocardial infarction within the previous 6 months
Other illness
- Heart failure (NYHA class III-IV)
Other
- ECOG PS \>2
Who the study is looking for
- Written informed consent provided
- Patients older than 18 years
- Histologically- or cytologically-proven pancreatic ductal adenocarcinoma (PDAC)
- Tumour lesion amenable for laparoscopic, surgical biopsy
- Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
- Radiologically measurable disease
- Life expectancy \> 3 months
- Absolute neutrophile count \>1500/microL, platelets \>100'000/microL
- Serum creatinine \<1.5 times of the upper limit of normal or Clearance \>50ml/min (according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula)
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hirslanden Kliniks Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.