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Evaluation and Comparison of the Growth Rate of Pancreatic Cancer Patient-derived Organoids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03990675
Recruitment Status : Recruiting
First Posted : June 19, 2019
Last Update Posted : June 19, 2019
Information provided by (Responsible Party):
Technische Universität München

Brief Summary:

Pancreatic ductal adenocarcinoma (PDAC) is one of the most aggressive forms of cancer. Despite advances in the understanding of the mechanisms underlying PDAC pathogenesis, the impact on patient benefit is lagging. As a result, new model systems are being developed and used to fill this gap with the hope of translation into improved diagnostics and therapeutics.

Organoids represent a powerful tool for research with the capacity to be applied to many key aspects of pancreatic tissue pathology.

3D organoids can be generated from endoscopic fine-needle aspiration or fine needle biopsy samples. In this study, we will evaluate and compare the growth rate of pancreatic cancer patient-derived organoids generated from matched fine needle Aspirations (FNA) and fine needle biopsies (FNB).

Condition or disease Intervention/treatment Phase
Pancreas Cancer Procedure: FNA, FNB Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation and Comparison of the Growth Rate of Pancreatic Cancer Patient-derived Organoids Generated From Matched Fine Needle Aspirations (FNA) and Fine Needle Biopsies (FNB)
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: FNA, FNB Procedure: FNA, FNB
Endoscopic ultrasound guided fine needle aspiration, Endoscopic ultrasound guided fine needle biopsy

Primary Outcome Measures :
  1. Growth rate [ Time Frame: 4 days ]
    Organoid growth will be determined using bi-weekly measurements by phase-contrast microscopy calculating the total organoid area as well as individual organoid size. In addition, growth rates will be determined using the cell glow assay (Promega) over a time-course of 4 days. Furthermore, the mean passaging time will be calculated after 5 passages.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients with indication for EUS-guided FNA or FNB of a suspected pancreatic malignancy

Exclusion Criteria:

  • < 18 years
  • patients unable to give consent

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 identifier (NCT number): NCT03990675

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Contact: Christoph Schlag, MD +49 89 4140 9357
Contact: Maximilian Reichert, MD +49 89 4140 9454

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2nd Medical Department, Klinikum rechts der Isar Recruiting
Munich, Germany, 81675
Contact: Christoph Schlag, MD    +49 89 4140 9357   
Sub-Investigator: Johannes R Wiessner, MD         
Principal Investigator: Maximilian Reichert, MD         
Principal Investigator: Christoph Schlag, MD         
Sponsors and Collaborators
Technische Universität München

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Responsible Party: Technische Universität München Identifier: NCT03990675     History of Changes
Other Study ID Numbers: Pancreatic cancer organoids
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019

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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
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases