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

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ClinicalTrials.gov Identifier: NCT02393703
Recruitment Status : Active, not recruiting
First Posted : March 19, 2015
Last Update Posted : May 2, 2019
Sponsor:
Collaborators:
Weill Medical College of Cornell University
National Institutes of Health (NIH)
University of Pittsburgh
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease
Pancreatic Cancer Benign Pancreatic Disease

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Study Type : Observational
Actual Enrollment : 69 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 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
blood, pancreatic fluid, and pancreas tissue


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
Study Population
MSKCC clinic
Criteria

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

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


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
National Institutes of Health (NIH)
University of Pittsburgh
Investigators
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Principal Investigator: William Jarnagin, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02393703     History of Changes
Other Study ID Numbers: 15-015
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019
Keywords provided by Memorial Sloan Kettering Cancer Center:
exosomes
15-015
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Pancreatic Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases