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

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

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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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.

November 15, 2022Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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