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Completed

NCT Number: NCT03549546

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

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.

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Key information

Conditions

Lung Cancer Cytopenia Diabetes Mellitus, Insulin-Dependent, 12 Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunologic Deficiency Syndromes Leukocyte Disorders Leukopenia Lung Diseases Lung Neoplasms Lymphopenia Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Surgery Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Saint-Etienne

Saint-Etienne, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. PD-1, TIM-3, CTLA4 on CD4/CD8 lymphocytes

    Time frame: 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 outcomes

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

    Time frame: 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

  2. pneumonia

    Time frame: Days 3

    To analyse the occurrence of postoperative pneumonia.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: POIR

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 8, 2018
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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