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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02393703
• Other study ID #: 15-015
• Status: Recruiting
• Start date: March 2015
• Est. completion date: March 2025

Study information

• Verified date: November 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: William Jarnagin, MD
• Phone: 212-639-7601
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 111
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• The presence of metastatic disease or disease that precludes resection
• Receipt of neoadjuvant chemotherapy or 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

Related Conditions & MeSH terms

• Benign Pancreatic Disease
• Pancreatic Cancer
• Pancreatic Diseases
• Pancreatic Neoplasms

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Institutes of Health (NIH), University of Pittsburgh, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	evaluation of the liver microenvironment	for alterations in cellular infiltrate and ECM using IF and IHC	1 year

External Links

•   Memorial Sloan Kettering Cancer Center