Expression of the Inhibitory Receptors on Lymphocytes T Cells After Lung Cancer Surgery.

Not Applicable

Completed

• Conditions: Surgery; Lung Cancer
• Interventions: Biological: Blood samples

• Registration Number: NCT03549546
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study First Submitted: 2018-05-25
• Study First Submitted QC: 2018-05-25
• Study First Posted: 2018-06-08
• Study Start: 2018-06-14
• Status Verified: 2018-12
• Primary Completion: 2019-02-06
• Study Completion: 2019-02-12
• Last Update Submitted: 2019-07-25
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients undergoing lung cancer surgery	Blood samples	Patients undergoing lung cancer surgery will be included. Blood samples will be collected.

Primary Outcome Measures

Name	Time	Method
PD-1, TIM-3, CTLA4 on CD4/CD8 lymphocytes	Days 0, 1, 3	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

Name	Time	Method
functionality of CD4/CD8 lymphocytes and production of IF gamma, TNF and IL-2	Days 0, 1, 3	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	Days 3	To analyse the occurrence of postoperative pneumonia.

Trial Locations

Locations (1)

CHU Saint-Etienne; 🇫🇷 Saint-Étienne, France