Back to resultsEvaluation of the Impact of Pancreatectomy on Systemic Immunity (IMMUNOPANC)
Primary Purpose
Pancreas Cancer, Pancreatectomy; Hyperglycemia
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
About this trial
This is an interventional basic science trial for Pancreas Cancer focused on measuring Pancreatectomy, Immune system
Eligibility Criteria
Inclusion Criteria:
- Patient with an indication of pancreatectomy
- Signed consent form
Exclusion Criteria:
- Neoadjuvant treatment
- Pregnancy
Sites / Locations
- Institut Paoli Calmettes
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Indication for pancreatectomy
Arm Description
Blood sampling at different time points before and after pancreatectomy
Outcomes
Primary Outcome Measures
Measurement of immune effectors (Tcells, NK) levels after pancreatectomy
Evaluation of immune effectors my mass cytometry after pancreatectomy (compared to baseline)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03978702
Brief Title
Evaluation of the Impact of Pancreatectomy on Systemic Immunity
Acronym
IMMUNOPANC
Official Title
Pancreatic Surgery: Evaluation of the Impact of Pancreatectomy on Systemic Immunity
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
July 27, 2022 (Anticipated)
Study Completion Date
July 27, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Paoli-Calmettes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aims at establishing the profile of the immune reaction that occurs in the early surgical suites after pancreatectomy. Blood samples will be collected before surgery, (Day-1), at day0, and after surgery at Day 1, Day 3, Day 7 at 1 year after pancreatectomy. Mass cytometry, genomic and transcriptomic approaches will be used to evaluate the immune systemic modulation after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer, Pancreatectomy; Hyperglycemia
Keywords
Pancreatectomy, Immune system
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Indication for pancreatectomy
Arm Type
Experimental
Arm Description
Blood sampling at different time points before and after pancreatectomy
Intervention Type
Other
Intervention Name(s)
Blood sampling
Intervention Description
20 mL will be collected at each time point (day-1,day 0, day 1, day 3, day 7, 1 year after pancreatectomy)
Primary Outcome Measure Information:
Title
Measurement of immune effectors (Tcells, NK) levels after pancreatectomy
Description
Evaluation of immune effectors my mass cytometry after pancreatectomy (compared to baseline)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with an indication of pancreatectomy
Signed consent form
Exclusion Criteria:
Neoadjuvant treatment
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Turrini, MD ¨PhD
Organizational Affiliation
Institut Paoli-Calmettes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Impact of Pancreatectomy on Systemic Immunity
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