- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2017-02-15
2020-02-25
2020-02-25
38
NCT03069599
Insel Gruppe AG, University Hospital Bern
Insel Gruppe AG, University Hospital Bern
OBSERVATIONAL
Immune Response After Pancreatic Cancer Treatment
The aim of this project is to describe the differential immunologic responses of patients who undergo in situ IRE, margin accentuation IRE with surgical resection of the primary tumor, and surgical resection of the primary tumor only. The primary hypothesis is that IRE induces a long and sustained activation of the cell-mediated immune system, which is distinct from the immune response after surgical resection only. The primary endpoint of this study is the comparison of the CD4+/CD8+ ratio as an indicator of antitumor immunity both longitudinally within a group after the intervention and over time between the three groups. CD4+/CD8+ ratio will be measured preoperatively and at postoperative days 1, 7, 42, and 180. As a secondary outcome, additional measurements will be taken to more specifically characterize the immune response based on peripheral blood samples. Flow cytometry will be used to quantify cell subsets, and ELISA will be used to measure cytokine levels , at the same time-points as for the primary outcome. Each group of patients as described above will consist of 10 consecutive pancreatic cancer patients. Patients aged 18 or older with resectable, borderline resectable, or locally advanced pancreatic cancer will be included. Patients with locally advanced disease will undergo 3 months of preoperative chemotherapy with monitoring to exclude metastatic disease. Main exclusion criteria are cardiac conduction abnormalities and signs of distant metastasis.
N/A
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-12-20 | N/A | 2020-02-25 |
2017-03-02 | N/A | 2020-02-26 |
2017-03-03 | N/A | 2020-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : 10 IRE locally advanced patients undergoing in situ IRE for locally advanced pancreatic | PROCEDURE: irreversible electroporation (IRE)
|
| : 10 IRE borderline resection patients undergoing margin accentuation IRE for borderline resectable disease | PROCEDURE: irreversible electroporation (IRE)
|
| : 10 resection only patients undergoing surgical resection only |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Immunological outcome | flowcytometry | 42 days |
| Immunological outcome | Flowcytometry | 6 months |
| Immunological outcome | Flowcytometry | 9 months |
| Immunological outcome | ELISA | 42 days |
| Immunological outcome | ELISA | 6 months |
| Immunological outcome | ELISA | 9 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number of local tumor recurrences | measured via CT | 42 days |
| Number of local tumor recurrences | measured via CT | 3 months |
| Number of local tumor recurrences | measured via CT | 6 months |
| Number of local tumor recurrences | measured via CT | 9 months |
| Number of distant tumor recurrences | measured via CT | 42 days |
| Number of distant tumor recurrences | measured via CT | 3 months |
| Number of distant tumor recurrences | measured via CT | 6 months |
| Number of distant tumor recurrences | measured via CT | 9 months |
| Overall survival | survival of patient | 42 days |
| Overall survival | survival of patient | 3 months |
| Overall survival | survival of patient | 6 months |
| Overall survival | survival of patient | 9 months |
| Cancer specific survival | survival of patient | 42 days |
| Cancer specific survival | survival of patient | 3 months |
| Cancer specific survival | survival of patient | 6 months |
| Cancer specific survival | survival of patient | 9 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
