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Association Between Circulating Immune Cells and the Tumor Immune Contexture in Resectable Non-small Cell Lung Cancer (LYMPHOLUNG)

Primary Purpose

Resectable Non-small Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood drawn
surgical resection of cancer
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Resectable Non-small Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women over 18 years of age
  • Histologically- or cytologically- confirmed non-small cell lung cancer diagnostic
  • Stage I, II or IIIA NSCLC (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology). Staging must have included an abdominal and thoracic CTscan, a CTscan or MRI of the brain and a 18FDG PETscan
  • Subjects for whom a surgical resection is indicated
  • Signed written informed consent

Exclusion Criteria:

  • - previous, ongoing or planned neo-adjuvant treatment (chemotherapy, targeted therapy, immunotherapy or radiotherapy)
  • contraindications to general anesthesia
  • contraindication to the planned surgical resection
  • history of immunosuppressive disorder
  • known history of testing positive for human immunodeficiency virus
  • subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 30 days of randomization.
  • clinical suspicion of active infection (either acute or chronic)
  • severe (hemoglobin < 8.0 g/dL) or symptomatic anemia
  • women of childbearing potential must have a negative urine pregnancy test
  • women must not be breastfeeding
  • prisoners or subjects who are involuntarily incarcerated
  • subjects under guardianship

Sites / Locations

  • Rouen University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with resectable non-small cell lung cancer

Arm Description

Outcomes

Primary Outcome Measures

Level of expression of the T regulator over total lymphocytes count ratio in the blood
Level of expression of the T regulator over total lymphocytes count ratio into the tumor

Secondary Outcome Measures

Number of cell population counts as blood markers for the corresponding population in the tumor
Number of patient alive 2 years after resection

Full Information

First Posted
September 14, 2015
Last Updated
May 25, 2018
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT02551211
Brief Title
Association Between Circulating Immune Cells and the Tumor Immune Contexture in Resectable Non-small Cell Lung Cancer
Acronym
LYMPHOLUNG
Official Title
Association Between Circulating Immune Cells and the Tumor Immune Contexture in Resectable Non-small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 14, 2016 (Actual)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
With the recent approval of Nivolumab for second-line treatment of stage IIIb/IV non-small cell lung cancer (NSCLC), immune checkpoint inhibitors are entering the standard of care for lung cancer. Other immune checkpoint inhibitors are under evaluation, both in resectable and non-resectable NSCLC. In order to refine our use of these molecules, comprehensive data on the immune contexture of NSCLC are needed. Moreover,a blood marker of this contexture would allow physicians to monitor the immune status of their patient's tumor and though to evaluate the rightful place of immunotherapy in the multimodal treatment of NSCLC. No such blood marker has been validated so far. The LYMPHOLUNG study investigate the concordance between blood and intratumoral counts of immune cells in resectable stage I to IIIA NSCLC. By the use of 30-marker cytometry, a precise immune profile of NSCLC will be depicted. The prognostic value of the circulating and intra-tumoral T regulator over total lymphocytes ratio for 2-year recurrence-free survival will also be addressed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resectable Non-small Lung Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with resectable non-small cell lung cancer
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
blood drawn
Intervention Description
blood drawn
Intervention Type
Procedure
Intervention Name(s)
surgical resection of cancer
Primary Outcome Measure Information:
Title
Level of expression of the T regulator over total lymphocytes count ratio in the blood
Time Frame
Day 1
Title
Level of expression of the T regulator over total lymphocytes count ratio into the tumor
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Number of cell population counts as blood markers for the corresponding population in the tumor
Time Frame
Day 1
Title
Number of patient alive 2 years after resection
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women over 18 years of age Histologically- or cytologically- confirmed non-small cell lung cancer diagnostic Stage I, II or IIIA NSCLC (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology). Staging must have included an abdominal and thoracic CTscan, a CTscan or MRI of the brain and a 18FDG PETscan Subjects for whom a surgical resection is indicated Signed written informed consent Exclusion Criteria: - previous, ongoing or planned neo-adjuvant treatment (chemotherapy, targeted therapy, immunotherapy or radiotherapy) contraindications to general anesthesia contraindication to the planned surgical resection history of immunosuppressive disorder known history of testing positive for human immunodeficiency virus subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 30 days of randomization. clinical suspicion of active infection (either acute or chronic) severe (hemoglobin < 8.0 g/dL) or symptomatic anemia women of childbearing potential must have a negative urine pregnancy test women must not be breastfeeding prisoners or subjects who are involuntarily incarcerated subjects under guardianship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bérengère OBSTOY, MD
Email
berengere.obstoy@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BLOT
Email
julien.blot@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bérengère OBSTOY
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bérengère OBSTOY, MD

12. IPD Sharing Statement

Learn more about this trial

Association Between Circulating Immune Cells and the Tumor Immune Contexture in Resectable Non-small Cell Lung Cancer

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