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

NCT ID: NCT02393703

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 181 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2027-03-31

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 Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Jarnagin, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

William Jarnagin, MD

Role: CONTACT

212-639-7601

Peter Kingham, MD

Role: CONTACT

212-639-5260

Facility Contacts

William R Jarnagin, MD

Role: primary

212-639-7601

Peter Kingham, MD

Role: backup

212-639-5260

Related Links

http://www.mskcc.org/

Memorial Sloan Kettering Cancer Center

Other Identifiers

15-015

Identifier Type: -

Identifier Source: org_study_id