Pancreatic CancerNCT03140592
Pancreatic Cancer Models Developed From EUS Guided Biopsy Tissue
An observational study of Pancreatic Cancer and Pancreatic Adenocarcinoma, run by Stony Brook University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreatic Adenocarcinoma, Pancreatic Cyst
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2015to Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
- Age ≥ 18 years
- Literate and able/willing to provide informed consent for participation in research.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Stony Brook University
Stony Brook, New York, 11794
Jonathan Buscaglia, MD, jonathan.buscaglia@stonybrookmedicine.edu
About this study
Official title: EUS-guided Biopsy of Pancreatic Mass Lesions for Developing Patient -Derived Cancer Models
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.
Read the 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.
- Being tested
- Biopsy
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Two extra EUS guided pancreatic biopsies collected for only research purposes.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start14 Jan 2015
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Buscaglia, Stony Brook University
- Investigators
- Jonathan Buscaglia, MD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140592
- Sponsor's protocol ID
- IRBNet # 618834
- Status last verified
- Mar 2021
- First submitted
- 2 May 2017
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32119924Tiriac 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.
PubMed 29325707
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS-guided Biopsy of Pancreatic Mass Lesions for Developing Patient -Derived Cancer Models
- ClinicalTrials.gov ID
- NCT03140592
- Acronym / sponsor ID
- IRBNet # 618834
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 14 Jan 2015 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
- Age ≥ 18 years
- Literate and able/willing to provide informed consent for participation in research.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyTwo extra EUS guided pancreatic biopsies collected for only research purposes. | Procedure or surgery | – |
Primary outcome
Successful generation of pancreatic organoids
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Derived from this study: PubMed 32119924Lacomb 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.
- Derived from this study: PubMed 29325707Tiriac 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Buscaglia, MD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer and Pancreatic Adenocarcinoma, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Buscaglia, MD (6314447225, jonathan.buscaglia@stonybrookmedicine.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful generation of pancreatic organoids (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03140592, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.