Evaluation and Comparison of the Growth Rate of Pancreati... | NCT03990675

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

NCT03990675

Sponsor

Technical University of Munich

Status

Unknown status

Last Update Posted

Jun 19, 2019Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Pancreas Cancer

Interventions

FNA, FNB

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2018Actual

Primary Completion Date

Aug 1, 2021Estimated

Completion Date

Aug 1, 2022Estimated

First Submitted Date

Jun 17, 2019

First Submission Date that Met QC Criteria

Jun 17, 2019

First Posted Date

Jun 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2019

Last Update Posted Date

Jun 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FNA, FNB	Experimental		Procedure: FNA, FNB

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FNA, FNB	Procedure	Endoscopic ultrasound guided fine needle aspiration, Endoscopic ultrasound guided fine needle biopsy	FNA, FNB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christoph Schlag, MD	Contact	+49 89 4140 9357		christoph.schlag@mri.tum.de
Maximilian Reichert, MD	Contact	+49 89 4140 9454		maximilian.reichert@tum.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
2nd Medical Department, Klinikum rechts der Isar	Recruiting	Munich		81675	Germany

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided