Interrogation Of Exosome-mediated Intercellular Signaling In Patients With Pancreatic Cancer

Study Overview

Interrogation of Exosome-mediated Intercellular Signaling in Patients With Pancreatic Cancer

The purpose of this study is to isolate and analyze exosomes, which are tiny carriers of important proteins and nucleic acids that serve as messenger systems in the blood and tissue. Blood and tissue from patients with pancreatic cancer will be compared with blood and tissue from patients with noncancerous pancreatic disease. Including patients without cancer will allow the investigators to establish "normal" values, which currently do not exist. The investigators will then look to see whether exosome activity has a connection to disease recurrence and outcomes in patients. The results of this study will be the basis for future studies exploring this area.

N/A

Pancreatic Cancer
Benign Pancreatic Disease

15-015

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-03-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-02-05
First Submitted that Met QC Criteria 2015-03-13	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-02-10
First Posted (ACTUAL) 2015-03-19	Results First Posted N/A	Last Verified 2025-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
successful isolation of exosomes	isolation of at least 100,000 microvesicles is needed for exosomes purification for down stream applications such as proteomics and RNA sequencing.	1 year

Secondary Outcome Measures	Measure Description	Time Frame
evaluation of the liver microenvironment	for alterations in cellular infiltrate and ECM using IF and IHC	1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: William Jarnagin, MD

Phone Number: 212-639-7601

Email:

Study Contact Backup

Name: Peter Kingham, MD

Phone Number: 212-639-5260

Email:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

All patients ≥ 18 years of age undergoing pancreaticoduodenectomy, partial or complete pancreatectomy, and duodenal ampullectomy for presumed ductal adenocarcinoma, intraductal papillary mucinous neoplasm (IPMN) or pancreatic neuroendocrine tumors, without an invasive component; or other benign pancreatic disease will be eligible.
For third part of the study, recipient of neoadjuvant chemotherapy will be accrued to the neoadjuvant group (25 patients). Patients without neoadjuvant chemotherapy will be accrued to the non-neoadjuvant group (25 patients).

The presence of metastatic disease or disease that precludes resection
For first and second part of the study, receipt of neoadjuvant chemotherapy or radiation for the index cancer within 6 months of being enrolled in the study
For third part of the study, receipt of neoadjuvant radiation for the index cancer within 6 months of being enrolled in the study
INR >2
Known clotting factor deficiency or hypercoagulable state
Any patient with the need or anticipated need for full anti-coagulation during hospitalization for the resection.
Receipt of antiplatelet agents (other than aspirin) in the preceding week prior to resection.
IPMN or pancreatic neuroendocrine tumors by radiographic imaging with high suspicion for invasive component Additionally, if at the discretion of the operating surgeon, blood collection would lead to undue morbidity, the patient will be excluded and replaced

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Weill Medical College of Cornell University
National Institutes of Health (NIH)
University of Pittsburgh

Investigators

PRINCIPAL_INVESTIGATOR: William Jarnagin, MD, Memorial Sloan Kettering Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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