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Brief 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.
Pancreatic Cancer Benign Pancreatic Disease
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Study Type :
Observational
Estimated Enrollment :
111 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Interrogation of Exosome-mediated Intercellular Signaling in Patients With Pancreatic Cancer
Actual Study Start Date :
March 2015
Estimated Primary Completion Date :
March 2024
Estimated Study Completion Date :
March 2024
Resource links provided by the National Library of Medicine
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Primary Outcome Measures :
successful isolation of exosomes [ Time Frame: 1 year ]
isolation of at least 100,000 microvesicles is needed for exosomes purification for down stream applications such as proteomics and RNA sequencing.
Secondary Outcome Measures :
evaluation of the liver microenvironment [ Time Frame: 1 year ]
for alterations in cellular infiltrate and ECM using IF and IHC
Biospecimen Retention: Samples With DNAblood, pancreatic fluid, and pancreas tissue
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Information from the National Library of Medicine
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Sampling Method:
Non-Probability Sample
MSKCC clinic
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
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393703
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Contact: William Jarnagin, MD
212-639-7601
Contact: Peter Kingham, MD
212-639-5260
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Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Contact: William R Jarnagin, MD 212-639-7601
Contact: Peter Kingham, MD 212-639-5260
Principal Investigator: William R Jarnagin, MD
Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
National Institutes of Health (NIH)
University of Pittsburgh
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Principal Investigator:
William Jarnagin, MD
Memorial Sloan Kettering Cancer Center
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Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02393703
Other Study ID Numbers:
15-015
First Posted:
March 19, 2015 Key Record Dates
Last Update Posted:
November 14, 2022
Last Verified:
November 2022
Keywords provided by Memorial Sloan Kettering Cancer Center:
exosomes15-015
Additional relevant MeSH terms:
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Pancreatic NeoplasmsPancreatic DiseasesDigestive System NeoplasmsNeoplasms by Site
NeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesEndocrine System Diseases
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
