- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02393703
Interrogation of Exosome-mediated Intercellular Signaling in Patients With Pancreatic Cancer
February 5, 2026 updated by: Memorial Sloan Kettering Cancer Center
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
181
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: William Jarnagin, MD
- Phone Number: 212-639-7601
Study Contact Backup
- Name: Peter Kingham, MD
- Phone Number: 212-639-5260
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Contact:
- Peter Kingham, MD
- Phone Number: 212-639-5260
-
Contact:
- William R Jarnagin, MD
- Phone Number: 212-639-7601
-
Principal Investigator:
- William R Jarnagin, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
MSKCC clinic
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
evaluation of the liver microenvironment
Time Frame: 1 year
|
for alterations in cellular infiltrate and ECM using IF and IHC
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
evaluation of the omental microenvironment
Time Frame: 1 year
|
for alterations in cellular infiltrate and ECM using IF and IHC
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: William Jarnagin, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2015
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Study Registration Dates
First Submitted
March 6, 2015
First Submitted That Met QC Criteria
March 13, 2015
First Posted (Estimated)
March 19, 2015
Study Record Updates
Last Update Posted (Actual)
February 9, 2026
Last Update Submitted That Met QC Criteria
February 5, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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