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Evaluation of the Impact of Pancreatectomy on Systemic Immunity (IMMUNOPANC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03978702
Recruitment Status : Not yet recruiting
First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Information provided by (Responsible Party):
Institut Paoli-Calmettes

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.

Condition or disease Intervention/treatment Phase
Pancreas Cancer Pancreatectomy; Hyperglycemia Other: Blood sampling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pancreatic Surgery: Evaluation of the Impact of Pancreatectomy on Systemic Immunity
Estimated Study Start Date : October 20, 2019
Estimated Primary Completion Date : October 20, 2022
Estimated Study Completion Date : October 20, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Indication for pancreatectomy
Blood sampling at different time points before and after pancreatectomy
Other: Blood sampling
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 Measures :
  1. Measurement of immune effectors (Tcells, NK) levels after pancreatectomy [ Time Frame: 1 year ]
    Evaluation of immune effectors my mass cytometry after pancreatectomy (compared to baseline)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient with an indication of pancreatectomy
  • Signed consent form

Exclusion Criteria:

  • Neoadjuvant treatment
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03978702

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Contact: Dominique Genre, MD +33491223778

Sponsors and Collaborators
Institut Paoli-Calmettes
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Principal Investigator: Olivier Turrini, MD ¨PhD Institut Paoli-Calmettes

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Responsible Party: Institut Paoli-Calmettes Identifier: NCT03978702     History of Changes
Other Study ID Numbers: IMMUNOPANC-IPC 2018-051
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Paoli-Calmettes:
Immune system
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Digestive System Diseases
Endocrine System Diseases