Back to resultsExpression of the Inhibitory Receptors on Lymphocytes T Cells After Lung Cancer Surgery. (POIR)
Primary Purpose
Lung Cancer, Surgery
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samples
Sponsored by
About this trial
This is an interventional basic science trial for Lung Cancer focused on measuring Lymphopenia, Lung cancer surgery, TIM-3, PD-1, CTLA-4, lymphocytes, CD4, CD8
Eligibility Criteria
Inclusion Criteria:
- Patient ≥ 18 years undergoing lung cancer surgery by thoracoscopy
Exclusion Criteria:
- Patient under guardianship/curatorship
- Patient who received of radiotherapy or chemotherapy in the last 6 months
- Patient under immunosuppressive treatment or dose of corticoids over 10 mg/day prednisolone or equivalent
- Patient with history of malignant blood disease or auto-immune disease
- Patient suffering from HIV infection and
- Patients with pre-operative infection
- Patient with an empiric antibiotic therapy introduced at operating room
Sites / Locations
- CHU Saint-Etienne
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients undergoing lung cancer surgery
Arm Description
Patients undergoing lung cancer surgery will be included. Blood samples will be collected.
Outcomes
Primary Outcome Measures
PD-1, TIM-3, CTLA4 on CD4/CD8 lymphocytes
Correlation between expression of PD-1, TIM-3, CTLA4 on CD4/CD8 lymphocytes and the occurrence of lymphopenia.
Measured by blood sample before lung cancer surgery, the next day lung cancer surgery and 3 days after lung cancer surgery. Analyzed by multicolour immunolabelling in flow cytometry
Secondary Outcome Measures
functionality of CD4/CD8 lymphocytes and production of IF gamma, TNF and IL-2
Correlation between functionality of CD4/CD8 lymphocytes and production of interferon (IF) gamma, Tumor Necrosis Factor (TNF) and interleukine (IL-2).
Measured by blood sample before lung cancer surgery, the next day lung cancer surgery and 3 days after lung cancer surgery. Analyzed by multicolour immunolabelling in flow cytometry
pneumonia
To analyse the occurrence of postoperative pneumonia.
Full Information
NCT ID
NCT03549546
First Posted
May 25, 2018
Last Updated
July 25, 2019
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT03549546
Brief Title
Expression of the Inhibitory Receptors on Lymphocytes T Cells After Lung Cancer Surgery.
Acronym
POIR
Official Title
Expression of the Inhibitory Receptors on Lymphocytes T Cells After Lung Cancer Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
June 14, 2018 (Actual)
Primary Completion Date
February 6, 2019 (Actual)
Study Completion Date
February 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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
Postoperative pneumonia is one of the most common complications after lung cancer surgery and associated with a morbidity and mortality. Postoperative lymphopenia has been recently identified as one of risk factors for postoperative pneumonia. According to recent studies in polytrauma, cancer or septic shock, T cells dysfunction may be related to high expression of inhibitory receptors on lymphocytes.
Detailed Description
This study will investigate prospectively TIM-3, PD-1 and CTLA4 expression on lymphocytes T cells before and after lung cancer surgery. Patients ≥ 18 years with no history of immunosuppressive state will be included.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Surgery
Keywords
Lymphopenia, Lung cancer surgery, TIM-3, PD-1, CTLA-4, lymphocytes, CD4, CD8
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
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients undergoing lung cancer surgery
Arm Type
Other
Arm Description
Patients undergoing lung cancer surgery will be included. Blood samples will be collected.
Intervention Type
Biological
Intervention Name(s)
Blood samples
Intervention Description
Blood samples will be collected in patients undergoing lung cancer surgery:
before lung cancer surgery,
the next day lung cancer surgery,
3 days after lung cancer surgery. They will be treated in flow cytometry.
Primary Outcome Measure Information:
Title
PD-1, TIM-3, CTLA4 on CD4/CD8 lymphocytes
Description
Correlation between expression of PD-1, TIM-3, CTLA4 on CD4/CD8 lymphocytes and the occurrence of lymphopenia.
Measured by blood sample before lung cancer surgery, the next day lung cancer surgery and 3 days after lung cancer surgery. Analyzed by multicolour immunolabelling in flow cytometry
Time Frame
Days 0, 1, 3
Secondary Outcome Measure Information:
Title
functionality of CD4/CD8 lymphocytes and production of IF gamma, TNF and IL-2
Description
Correlation between functionality of CD4/CD8 lymphocytes and production of interferon (IF) gamma, Tumor Necrosis Factor (TNF) and interleukine (IL-2).
Measured by blood sample before lung cancer surgery, the next day lung cancer surgery and 3 days after lung cancer surgery. Analyzed by multicolour immunolabelling in flow cytometry
Time Frame
Days 0, 1, 3
Title
pneumonia
Description
To analyse the occurrence of postoperative pneumonia.
Time Frame
Days 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient ≥ 18 years undergoing lung cancer surgery by thoracoscopy
Exclusion Criteria:
Patient under guardianship/curatorship
Patient who received of radiotherapy or chemotherapy in the last 6 months
Patient under immunosuppressive treatment or dose of corticoids over 10 mg/day prednisolone or equivalent
Patient with history of malignant blood disease or auto-immune disease
Patient suffering from HIV infection and
Patients with pre-operative infection
Patient with an empiric antibiotic therapy introduced at operating room
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume Dupont, MD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Saint-Etienne
City
Saint-Étienne
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Expression of the Inhibitory Receptors on Lymphocytes T Cells After Lung Cancer Surgery.
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