Etude : LYMPHOLUNG /



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : LYMPHOLUNG

Nom :

Traitement :

Type d'étude : Qualité de vie / Observationnelle

Dernière MÀJ : 28/11/2019
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Association Between Circulating Immune Cells and the Tumor Immune Contexture in Resectable Non-small Cell Lung Cancer

Spécialité : Organes respiratoires et intrathoraciques
Localisation : C34 - Tumeur maligne des bronches et du poumon
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : 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.

Phase : NA

Stade : NA

NA
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : 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 consen

Critères de non-inclusion : 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
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT02551211
Promoteur :
CHU de Rouen
Type de sponsor : Institutionnel
76000 ROUEN

Coordonnateur :
Dr Bérengère OBSTOY
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
CHU de Rouen - 1 Rue de Germont - 76000 ROUEN

Investigateur :
Florian GUISIER

TEC / ARC / IDE :
Carine BOYENVAL
carine.boyenval@
chu-rouen.fr
02 32 88 80 79 poste 62 512

Statut de l'essai : OUVERT

MAJ : 28/11/2019