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Patient-derived Organoids Drug Screen in Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT05351983
Recruitment Status : Recruiting
First Posted : April 28, 2022
Last Update Posted : October 25, 2022
Information provided by (Responsible Party):
Prof. Dr. med. Dres. h.c. Jan Schmidt, MME, Klinik Hirslanden, Zurich

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Pancreas Cancer Pancreas Neoplasm Pancreas Adenocarcinoma Pancreatic Cancer Pancreatic Neoplasms Pancreatic Adenocarcinoma Procedure: Surgical biopsy of tumoral tissue for organoid generation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Patient-derived Organoid Generation in Pancreatic Cancer: a Single Centre, Open-label, Single Arm Feasibility Study
Actual Study Start Date : September 22, 2022
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Organoid generation
All patients will included in a single-arm. Participants will undergo biopsy of tumor tissue for subsequent organoid generation.
Procedure: Surgical biopsy of tumoral tissue for organoid generation
In surgically-resectable lesions, tumoral samples will be collected from the main surgical specimens, before sending it for final pathological examination. Patients with metastatic disease, will be offered to undergo port-a-cath implantation for chemotherapy delivery and concomitant laparoscopic surgical excisional biopsy of suspicious metastatic lesions. Intraoperative frozen section will confirm the presence of malignant cells in the sample. Part of the specimen will be sent for assessment of contamination by bacterial and/or fungal flora by the Microbiology Laboratory. The remaining tumour sample will be sent for patient-derived organoid (PDO) formation. Two patients' blood samples will be retrieved in ethylenediaminetetraacetic acid (EDTA) tubes and will be sent with the surgical specimen. All patients will then receive the standard of care (SOC) treatment according to the clinical judgement of the oncologist in charge, always within the framework of the international guidelines.

Primary Outcome Measures :
  1. Feasibility of the process [ Time Frame: 30 days after the last patient enrollment. ]
    To determine the proportion of patients (specifically, the percentage with respect to the total sample enrolled in the study) for which organoids can be successfully generated and in which an effective treatment can be identified by drug screens in these patient-derived organoids. Successful generation of organoids will be defined as the presence of individual three-dimensional structures within 10 days from the begin of generation process. Effective treatment is considered a treatment decreasing of 50% (or more) the viability of patient-derived organoids.

Secondary Outcome Measures :
  1. Safety of surgical biopsy and post-operative surgical complications. [ Time Frame: 30 days post-operatively ]
    To evaluate safety of surgical biopsy for patient-derived organoids generation in patients with pancreatic cancer. Safety will be evaluated in terms of absolute and relative (%) number of postoperative complications. Severity will be graded according the Clavien-Dindo classification for surgical complications: complications equal to or greater than grade 3B will be considered as "severe". Management of each complication will be recorded for descriptive purposes.

  2. Contamination rates [ Time Frame: 30 days after the last patient enrollment. ]
    To assess the rate of contaminated samples by endogenous bacterial and fungal flora and to highlight possible implications in patient-derived organoid testing response.

  3. Chemosensitivity testing [ Time Frame: 6 days after the last organoid generation ]
    To assess in vitro efficacy of different chemotherapeutic regimens (and their combinations). In vitro efficacy will be evaluated based on the drug's (or drug combination's) capacity to decrease organoid viability of more than 50% after 6 days from their administration. Drugs (or their combination) tested in vitro will include Oxaliplatin, Carboplatin, Cisplatin, SN-38 (Irinotecan), Leucovorin, 5-FU, Gemcitabine, Olaparib, Nab-Paclitaxel, Nanoliposomal irinotecan (Nal-IRI), Niraparib.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • 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)

Exclusion criteria:

  • Concomitant need for full anticoagulation that cannot be interrupted or bridged prior to tissue biopsy
  • ECOG PS >2
  • Heart failure (NYHA class III-IV)
  • Severe or uncontrolled concurrent illness
  • Myocardial infarction within the previous 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05351983

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Contact: Jan Schmidt, Prof. Dr. med. Dres. h.c. MME + 41 44 209 25 05 Jan.Schmidt@hirslanden.ch

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Hirslanden Kliniks Recruiting
Zürich, Switzerland, 8002
Contact: Jan Schmidt, Prof. Dr. med. Dres. h.c. MME    + 41 44 209 25 05    chirurgie.impark@hirslanden.ch   
Sponsors and Collaborators
Prof. Dr. med. Dres. h.c. Jan Schmidt, MME
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Study Chair: Daniel Helbling, Dr. Med. Onkozentrum Zürich
Study Chair: Marianna Kruithof-De Julio, Prof. Dr. phil. University of Bern
Additional Information:
Tiriac H, Belleau P, Engle DD, Plenker D, Deschênes A, Somerville TDD, Froeling FEM, Burkhart RA, Denroche RE, Jang GH, Miyabayashi K, Young CM, Patel H, Ma M, LaComb JF, Palmaira RLD, Javed AA, Huynh JC, Johnson M, Arora K, Robine N, Shah M, Sanghvi R, Goetz AB, Lowder CY, Martello L, Driehuis E, LeComte N, Askan G, Iacobuzio-Donahue CA, Clevers H, Wood LD, Hruban RH, Thompson E, Aguirre AJ, Wolpin BM, Sasson A, Kim J, Wu M, Bucobo JC, Allen P, Sejpal DV, Nealon W, Sullivan JD, Winter JM, Gimotty PA, Grem JL, DiMaio DJ, Buscaglia JM, Grandgenett PM, Brody JR, Hollingsworth MA, O'Kane GM, Notta F, Kim E, Crawford JM, Devoe C, Ocean A, Wolfgang CL, Yu KH, Li E, Vakoc CR, Hubert B, Fischer SE, Wilson JM, Moffitt R, Knox J, Krasnitz A, Gallinger S, Tuveson DA. Organoid Profiling Identifies Common Responders to Chemotherapy in Pancreatic Cancer. Cancer Discov. 2018 Sep;8(9):1112-1129. doi: 10.1158/2159-8290.CD-18-0349. Epub 2018 May 31.

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Responsible Party: Prof. Dr. med. Dres. h.c. Jan Schmidt, MME, Principal Investigator, Klinik Hirslanden, Zurich
ClinicalTrials.gov Identifier: NCT05351983    
Other Study ID Numbers: HIRSLANDEN_PANC_001
First Posted: April 28, 2022    Key Record Dates
Last Update Posted: October 25, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases