NCT03978702

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
1.7 years until next milestone

Study Start

First participant enrolled

February 24, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2022

Completed
Last Updated

January 6, 2022

Status Verified

May 1, 2021

Enrollment Period

1.4 years

First QC Date

June 3, 2019

Last Update Submit

January 5, 2022

Conditions

Pancreas CancerPancreatectomy; Hyperglycemia

Keywords

PancreatectomyImmune system

Outcome Measures

Primary Outcomes (1)

  • Measurement of immune effectors (Tcells, NK) levels after pancreatectomy

    Evaluation of immune effectors my mass cytometry after pancreatectomy (compared to baseline)

    1 year

Study Arms (1)

Indication for pancreatectomy

EXPERIMENTAL

Blood sampling at different time points before and after pancreatectomy

Other: Blood sampling

Interventions

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)

Indication for pancreatectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with an indication of pancreatectomy
  • Signed consent form

You may not qualify if:

  • Neoadjuvant treatment
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli Calmettes

Marseille, 13009, France

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsHyperglycemia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Olivier Turrini, MD ¨PhD

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2019

First Posted

June 7, 2019

Study Start

February 24, 2021

Primary Completion

July 27, 2022

Study Completion

July 27, 2022

Last Updated

January 6, 2022

Record last verified: 2021-05

Locations

FR(1)