Pancreas CancerIMMUNOPANCNCT03978702
Evaluation of the Impact of Pancreatectomy on Systemic Immunity
A study testing Blood sampling in people with Pancreas Cancer and Pancreatectomy; Hyperglycemia, run by Institut Paoli-Calmettes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Pancreatectomy; Hyperglycemia
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2021to 27 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with an indication of pancreatectomy
- Signed consent form
Who cannot join
- Neoadjuvant treatment
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pancreatic Surgery: Evaluation of the Impact of Pancreatectomy on Systemic Immunity
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.
- Conditions
- Pancreas Cancer, Pancreatectomy; Hyperglycemia
- Being tested
- Blood sampling
- Keywords
- Pancreatectomy, Immune system
- Medical subject headings
- Pancreatic Neoplasms, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
20 mL will be collected at each time point (day-1,day 0, day 1, day 3, day 7, 1 year after pancreatectomy)
| Study group | Role | What they receive |
|---|---|---|
| Indication for pancreatectomy | Experimental | Blood sampling at different time points before and after pancreatectomy Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of immune effectors (Tcells, NK) levels after pancreatectomy
Evaluation of immune effectors my mass cytometry after pancreatectomy (compared to baseline)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start24 Feb 2021
- Primary completion27 Jul 2022 (estimated)
- Study completion27 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Turrini, MD ¨PhD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978702
- Sponsor's protocol ID
- IMMUNOPANC-IPC 2018-051
- Acronym
- IMMUNOPANC
- Status last verified
- May 2021
- First submitted
- 3 Jun 2019
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Surgery: Evaluation of the Impact of Pancreatectomy on Systemic Immunity
- ClinicalTrials.gov ID
- NCT03978702
- Acronym / sponsor ID
- IMMUNOPANC / IMMUNOPANC-IPC 2018-051
- Conditions
- Pancreas Cancer, Pancreatectomy; Hyperglycemia
- Keywords
- Pancreatectomy, Immune system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 27 Jul 2022 (estimated)
- Study completion
- 27 Jul 2022 (estimated)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indication for pancreatectomy | Experimental | Other: Blood samplingBlood sampling at different time points before and after pancreatectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with an indication of pancreatectomy
- Signed consent form
Key exclusion criteria (2 listed)
- Neoadjuvant treatment
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sampling20 mL will be collected at each time point (day-1,day 0, day 1, day 3, day 7, 1 year after pancreatectomy) | Other | Indication for pancreatectomy |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Turrini, MD ¨PhD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Pancreas Cancer and Pancreatectomy; Hyperglycemia, run by Institut Paoli-Calmettes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of immune effectors (Tcells, NK) levels after pancreatectomy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2022.