Clinical trial NCT02393703: Interrogation of Exosome-mediated Intercellular Signaling in Patients With Pancreatic Cancer
Official title: Interrogation of Exosome-mediated Intercellular Signaling in Patients With Pancreatic Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cancer
Benign Pancreatic Disease
Keywords: exosomes
15-015
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
name: National Institutes of Health (NIH)
name: University of Pittsburgh
First posted: 2015-03-19
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MSKCC clinic

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.


Eligibility 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.
* For third part of the study, recipient of neoadjuvant chemotherapy will be accrued to the neoadjuvant group (25 patients). Patients without neoadjuvant chemotherapy will be accrued to the non-neoadjuvant group (25 patients).

Exclusion Criteria:

* The presence of metastatic disease or disease that precludes resection
* For first and second part of the study, receipt of neoadjuvant chemotherapy or radiation for the index cancer within 6 months of being enrolled in the study
* For third part of the study, receipt of neoadjuvant 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

Primary outcomes:
measure: successful isolation of exosomes
timeFrame: 1 year
Secondary outcomes:
measure: evaluation of the liver microenvironment
timeFrame: 1 year
Other outcomes:
measure: evaluation of the omental microenvironment
timeFrame: 1 year
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: William Jarnagin, MD
role: PRINCIPAL_INVESTIGATOR
References: