Association Between Circulating Immune Cells and the Tumo... | NCT02551211

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

NCT02551211

Sponsor

University Hospital, Rouen

Status

Terminated

Last Update Posted

May 4, 2026Actual

Enrollment

22Actual

Phase

Not Applicable

Conditions

Resectable Non-small Lung Cancer

Interventions

blood drawn
surgical resection of cancer

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty in enrolling patients

Expanded Access Info

Start Date

Dec 14, 2016Actual

Primary Completion Date

Feb 10, 2020Actual

Completion Date

Feb 10, 2020Actual

First Submitted Date

Sep 14, 2015

First Submission Date that Met QC Criteria

Sep 15, 2015

First Posted Date

Sep 16, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2026

Last Update Posted Date

May 4, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with resectable non-small cell lung cancer	Experimental		Procedure: blood drawn Procedure: surgical resection of cancer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood drawn	Procedure	blood drawn	Patients with resectable non-small cell lung cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Level of expression of the T regulator over total lymphocytes count ratio in the blood		Day 1
Level of expression of the T regulator over total lymphocytes count ratio into the tumor		Day 1

Secondary Outcomes

Measure	Description	Time Frame
Number of cell population counts as blood markers for the corresponding population in the tumor		Day 1
Number of patient alive 2 years after resection		2 years

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided