Clinical trial NCT03140592: Pancreatic Cancer Models Developed From EUS Guided Biopsy Tissue
Official title: EUS-guided Biopsy of Pancreatic Mass Lesions for Developing Patient -Derived Cancer Models
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Cancer
Pancreatic Adenocarcinoma
Pancreatic Cyst
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are scheduled for an EUS-FNB performed by a member of the Stony Brook Interventional Endoscopy Section of the Division of Gastroenterology and Hepatology

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.

Eligibility criteria: 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

Primary outcomes:
measure: Successful generation of pancreatic organoids
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University
state: New York
Study officials:
affiliation: Stony Brook University
name: Jonathan Buscaglia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lacomb JF, Plenker D, Tiriac H, Bucobo JC, D'souza LS, Khokhar AS, Patel H, Channer B, Joseph D, Wu M, Tuveson DA, Li E, Buscaglia JM. Single-Pass vs 2-Pass Endoscopic Ultrasound-Guided Fine-Needle Biopsy Sample Collection for Creation of Pancreatic Adenocarcinoma Organoids. Clin Gastroenterol Hepatol. 2021 Apr;19(4):845-847. doi: 10.1016/j.cgh.2020.02.045. Epub 2020 Feb 29.
citation: Tiriac H, Bucobo JC, Tzimas D, Grewel S, Lacomb JF, Rowehl LM, Nagula S, Wu M, Kim J, Sasson A, Vignesh S, Martello L, Munoz-Sagastibelza M, Somma J, Tuveson DA, Li E, Buscaglia JM. Successful creation of pancreatic cancer organoids by means of EUS-guided fine-needle biopsy sampling for personalized cancer treatment. Gastrointest Endosc. 2018 Jun;87(6):1474-1480. doi: 10.1016/j.gie.2017.12.032. Epub 2018 Jan 9.