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

Lung Cancer Clinical Trial

— POIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03549546
• Other study ID #: 1708182
• Secondary ID: 2017-A03391-52
• Status: Completed
• Phase: N/A
• Start date: June 14, 2018
• Est. completion date: February 12, 2019

Study information

• Verified date: December 2018
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 12, 2019
• Est. primary completion date: February 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Surgery

Intervention

Biological:
• Blood samples
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.

Locations

Country	Name	City	State
France	CHU Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Days 0, 1, 3
Secondary	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	Days 0, 1, 3
Secondary	pneumonia	To analyse the occurrence of postoperative pneumonia.	Days 3