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

NCT03549546 | Completed

• 2 other identifiers: 17081822017-A03391-52
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Surgery

Keywords

Lymphopenia; Lung cancer surgery; TIM-3; PD-1; CTLA-4; lymphocytes; CD4; CD8

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• functionality of CD4/CD8 lymphocytes and production of IF gamma, TNF and IL-2

  Days 0, 1, 3

• pneumonia

  Days 3

Study Arms (1)

Patients undergoing lung cancer surgery

OTHER

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

Biological: Blood samples

Interventions

Blood samples BIOLOGICAL

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.

Patients undergoing lung cancer surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ≥ 18 years undergoing lung cancer surgery by thoracoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU Saint-Etienne

Saint-Etienne, France

Location

MeSH Terms

Conditions

Lung Neoplasms; Lymphopenia; Diabetes Mellitus, Insulin-Dependent, 12

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Guillaume Dupont, MD

  CHU SAINT-ETIENNE

  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: May 25, 2018
• First Posted: June 8, 2018
• Study Start: June 14, 2018
• Primary Completion: February 6, 2019
• Study Completion: February 12, 2019
• Last Updated: July 26, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)