Pancreatic Cancer Models Developed From EUS Guided Biopsy Tissue

• Conditions: Pancreatic Adenocarcinoma; Pancreatic Cyst; Pancreatic Cancer

• Registration Number: NCT03140592
• Lead Sponsor: Stony Brook University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-01-14
• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-04
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-18
• Last Update Posted: 2021-03-19
• Primary Completion: 2023-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

2. Age ≥ 18 years

3. 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful generation of pancreatic organoids	6 years	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.

Trial Locations

Locations (1)

Stony Brook University; 🇺🇸 Stony Brook, New York, United States