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出境医 / 临床实验 / Evaluation of the Impact of Pancreatectomy on Systemic Immunity (IMMUNOPANC)
Evaluation of the Impact of Pancreatectomy on Systemic Immunity (IMMUNOPANC)
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pancreas Cancer Pancreatectomy; Hyperglycemia | Other: Blood sampling | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | N/A |
| 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 |
| Actual Study Start Date : | February 24, 2021 |
| Estimated Primary Completion Date : | April 2022 |
| Estimated Study Completion Date : | April 2023 |
Arms and Interventions
| 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)
|
Outcome Measures
Primary Outcome Measures :
- 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)
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient with an indication of pancreatectomy
- Signed consent form
Exclusion Criteria:
- Neoadjuvant treatment
- Pregnancy
Contacts and Locations
Contacts
| Contact: Dominique Genre, MD | +33491223778 | drci.up@ipc.unicancer.fr |
Locations
| France | |
| Institut Paoli Calmettes | Recruiting |
| Marseille, France, 13009 | |
| Contact: GENRE Dominique, MD + 33 4 91 22 37 78 drci.up@ipc.unicancer.fr | |
| Contact: GOUARNE Caroline, PhD + 33 4 91 22 37 78 drci.up@ipc.unicancer.fr | |
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
| Principal Investigator: | Olivier Turrini, MD ¨PhD | Institut Paoli-Calmettes |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 3, 2019 | ||||
| First Posted Date ICMJE | June 7, 2019 | ||||
| Last Update Posted Date | May 7, 2021 | ||||
| Actual Study Start Date ICMJE | February 24, 2021 | ||||
| Estimated Primary Completion Date | April 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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)
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of the Impact of Pancreatectomy on Systemic Immunity | ||||
| Official Title ICMJE | Pancreatic Surgery: Evaluation of the Impact of Pancreatectomy on Systemic Immunity | ||||
| 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | 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)
|
||||
| Study Arms ICMJE | Experimental: Indication for pancreatectomy
Blood sampling at different time points before and after pancreatectomy
Intervention: Other: Blood sampling
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
40 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | April 2023 | ||||
| Estimated Primary Completion Date | April 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
|
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| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03978702 | ||||
| Other Study ID Numbers ICMJE | IMMUNOPANC-IPC 2018-051 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Institut Paoli-Calmettes | ||||
| Study Sponsor ICMJE | Institut Paoli-Calmettes | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
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| PRS Account | Institut Paoli-Calmettes | ||||
| Verification Date | May 2021 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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