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

Pancreas Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03990675
• Other study ID #: Pancreatic cancer organoids
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: August 1, 2022

Study information

• Verified date: June 2019
• Source: Technische Universität München
• Contact: Christoph Schlag, MD
• Phone: +49 89 4140 9357
• Email: christoph.schlag[@]mri.tum.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreas Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• FNA, FNB
Endoscopic ultrasound guided fine needle aspiration, Endoscopic ultrasound guided fine needle biopsy

Locations

Country	Name	City	State
Germany	2nd Medical Department, Klinikum rechts der Isar	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 days