NCT03990675

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

2.7 years

First QC Date

June 17, 2019

Last Update Submit

June 17, 2019

Conditions

Pancreas Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

FNA, FNB

EXPERIMENTAL
Procedure: FNA, FNB

Interventions

FNA, FNBPROCEDURE

Endoscopic ultrasound guided fine needle aspiration, Endoscopic ultrasound guided fine needle biopsy

FNA, FNB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \< 18 years
  • patients unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2nd Medical Department, Klinikum rechts der Isar

Munich, 81675, Germany

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Central Study Contacts

Christoph Schlag, MD

CONTACT

+49 89 4140 9357christoph.schlag@mri.tum.de

Maximilian Reichert, MD

CONTACT

+49 89 4140 9454maximilian.reichert@tum.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2019

First Posted

June 19, 2019

Study Start

December 1, 2018

Primary Completion

August 1, 2021

Study Completion

August 1, 2022

Last Updated

June 19, 2019

Record last verified: 2019-06

Locations

DE(1)