Pancreatic Cancer Models Developed From EUS Guided Biopsy Tissue

Pancreatic Cancer Clinical Trial

Official title:

EUS-guided Biopsy of Pancreatic Mass Lesions for Developing Patient -Derived Cancer Models

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03140592
• Other study ID #: IRBNet # 618834
• Status: Recruiting
• Start date: January 14, 2015
• Est. completion date: January 2023

Study information

• Verified date: March 2021
• Source: Stony Brook University
• Contact: Jonathan Buscaglia, MD
• Phone: 6314447225
• Email: jonathan.buscaglia[@]stonybrookmedicine.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Pancreatic cancer is a very aggressive cancer. Over the past 40 years there has not been much progress made in reducing deaths from this cancer. Recently, new models of pancreatic cancers have been generated from mouse and human tissues. These models have used larger pieces of tissues taken from surgical removal of pancreatic cancers.

The purpose of this study is to determine whether these new pancreatic cancer models can be generated from the small biopsies we take to make the diagnosis of the pancreatic mass.

Description:

The Endoscopic Ultrasound guided pancreatic biopsy tissue collected for only research purposes will be used to generate organoids in a in-vivo and in-vitro setting.

The development of these methods may help scientists identify new treatments for pancreatic cancer and to potentially develop more personalized approaches to treating pancreatic cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients who are scheduled for an EUS-FNB of pancreatic mass(es) suspicious for pancreatic ductal adenocarcinoma performed by a member of the Stony Brook Interventional Endoscopy Section of the Division of Gastroenterology and Hepatology

1. Age = 18 years

2. Literate and able/willing to provide informed consent for participation in research.

Exclusion Criteria:

1. Age < 18 years

2. Not literate or unable/unwilling to provide informed consent for EUS-FNB research biopsies

3. Pregnancy as determined by serum or urine HCG test performed as standard of clinical care for all women of childbearing age and documented on subjects' electronic medical record

Related Conditions & MeSH terms

• Pancreatic Adenocarcinoma
• Pancreatic Cancer
• Pancreatic Cyst
• Pancreatic Neoplasms

Intervention

Procedure:
• Biopsy
Two extra EUS guided pancreatic biopsies collected for only research purposes.

Locations

Country	Name	City	State
United States	Stony Brook University	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful generation of pancreatic organoids	The two extra biopsy tissues collected for only research purposes will be used to generate pancreatic organoids in a in-vivo as well as in-vitro setting.	6 years