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

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ClinicalTrials.gov Identifier: NCT03549546
Recruitment Status : Completed
First Posted : June 8, 2018
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Lung Cancer Surgery Biological: Blood samples Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Expression of the Inhibitory Receptors on Lymphocytes T Cells After Lung Cancer Surgery.
Actual Study Start Date : June 14, 2018
Actual Primary Completion Date : February 6, 2019
Actual Study Completion Date : February 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Patients undergoing lung cancer surgery
Patients undergoing lung cancer surgery will be included. Blood samples will be collected.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549546


Locations
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France
CHU Saint-Etienne
Saint-Étienne, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Guillaume Dupont, MD CHU SAINT-ETIENNE

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03549546     History of Changes
Other Study ID Numbers: 1708182
2017-A03391-52 ( Other Identifier: ID-RCB )
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Lymphopenia
Lung cancer surgery
TIM-3
PD-1
CTLA-4
lymphocytes
CD4
CD8

Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases