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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date November 2023
Source Memorial Sloan Kettering Cancer Center
Contact William Jarnagin, MD
Phone 212-639-7601
Is FDA regulated No
Health authority
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

Study Design


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
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