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NCT Number: NCT02393703

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Location status: Recruiting

Location contact

Peter Kingham, MD

CONTACT

212-639-5260

William R Jarnagin, MD

CONTACT

212-639-7601

William R Jarnagin, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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.

Secondary outcomes

  1. evaluation of the liver microenvironment

    Time frame: 1 year

    for alterations in cellular infiltrate and ECM using IF and IHC

Other outcomes

  1. evaluation of the omental microenvironment

    Time frame: 1 year

    for alterations in cellular infiltrate and ECM using IF and IHC

Study contacts

Contact information is provided by the study sponsor or research team.

Peter Kingham, MD

CONTACT

212-639-5260

William Jarnagin, MD

CONTACT

212-639-7601

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • National Institutes of Health (NIH)
  • University of Pittsburgh
  • Weill Medical College of Cornell University

Registry information

Important dates

Study start
2015
Primary completion
2027
Study completion
2027
First posted
Mar 19, 2015
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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