Pancreatic Cancer Clinical Trial
Official title:
Interrogation of Exosome-mediated Intercellular Signaling in Patients With Pancreatic Cancer
NCT number | NCT02393703 |
Other study ID # | 15-015 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | March 2025 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Memorial Sloan Kettering Cancer Center | National Institutes of Health (NIH), University of Pittsburgh, Weill Medical College of Cornell University |
United States,
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 |
Status | Clinical Trial | Phase | |
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