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

Not Applicable

• Conditions: Pancreas Cancer

• Registration Number: NCT03990675
• Lead Sponsor: Technical University of Munich

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Status Verified: 2019-06
• Study First Submitted: 2019-06-17
• Study First Submitted QC: 2019-06-17
• Last Update Submitted: 2019-06-17
• Study First Posted: 2019-06-19
• Last Update Posted: 2019-06-19
• Primary Completion: 2021-08-01
• Study Completion: 2022-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Growth rate	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.

Trial Locations

Locations (1)

2nd Medical Department, Klinikum rechts der Isar; 🇩🇪 Munich, Germany