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

Primary Purpose

Pancreas Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
FNA, FNB
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pancreas Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 2nd Medical Department, Klinikum rechts der IsarRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FNA, FNB

Arm Description

Outcomes

Primary Outcome Measures

Growth rate
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.

Secondary Outcome Measures

Full Information

First Posted
June 17, 2019
Last Updated
June 17, 2019
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT03990675
Brief Title
Evaluation and Comparison of the Growth Rate of Pancreatic Cancer Patient-derived Organoids
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FNA, FNB
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
FNA, FNB
Intervention Description
Endoscopic ultrasound guided fine needle aspiration, Endoscopic ultrasound guided fine needle biopsy
Primary Outcome Measure Information:
Title
Growth rate
Description
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.
Time Frame
4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christoph Schlag, MD
Phone
+49 89 4140 9357
Email
christoph.schlag@mri.tum.de
First Name & Middle Initial & Last Name or Official Title & Degree
Maximilian Reichert, MD
Phone
+49 89 4140 9454
Email
maximilian.reichert@tum.de
Facility Information:
Facility Name
2nd Medical Department, Klinikum rechts der Isar
City
Munich
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Schlag, MD
Phone
+49 89 4140 9357
Email
christoph.schlag@mri.tum.de
First Name & Middle Initial & Last Name & Degree
Johannes R Wiessner, MD
First Name & Middle Initial & Last Name & Degree
Maximilian Reichert, MD
First Name & Middle Initial & Last Name & Degree
Christoph Schlag, MD

12. IPD Sharing Statement

Learn more about this trial

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

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