Recruiting

Exosome Analysis

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT02393703

Conditions

Pancreatic Cancer

Benign Pancreatic Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Pancreatic Cancer

Benign Pancreatic Disease

Study ID

NCT02393703

Start date

Mar, 2015

Status verified date

Feb, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

181 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • successful isolation of exosomes [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

William Jarnagin, MD

212-639-7601

Peter Kingham, MD

212-639-5260

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

William R Jarnagin, MD

212-639-7601

Peter Kingham, MD

212-639-5260

Principal Investigator:

William R Jarnagin, MD

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Keywords

  • exosomes
  • 15-015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-02-09.