NCT03140592

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.

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

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

January 14, 2015

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

8 years

First QC Date

May 2, 2017

Last Update Submit

March 18, 2021

Conditions

Pancreatic CancerPancreatic AdenocarcinomaPancreatic Cyst

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

BiopsyPROCEDURE

Two extra EUS guided pancreatic biopsies collected for only research purposes.

Eligibility Criteria

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

You may qualify if:

  • \. 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
  • Age ≥ 18 years
  • Literate and able/willing to provide informed consent for participation in research.

You may not qualify if:

  • Age \< 18 years
  • Not literate or unable/unwilling to provide informed consent for EUS-FNB research biopsies
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University

Stony Brook, New York, 11794, United States

RECRUITING

Related Publications (2)

  • 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.

    PMID: 32119924DERIVED

  • 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.

    PMID: 29325707DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

biopsies of your pancreatic mass

MeSH Terms

Conditions

Pancreatic NeoplasmsPancreatic Cyst

Interventions

Biopsy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Jonathan Buscaglia, MD

    Stony Brook University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Buscaglia, MD

CONTACT

6314447225jonathan.buscaglia@stonybrookmedicine.edu

Joseph LaComb, BS

CONTACT

6314449532joseph.lacomb@stonybrookmedicine.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 2, 2017

First Posted

May 4, 2017

Study Start

January 14, 2015

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

March 19, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)