Etude : OBSTINATE /



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
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : OBSTINATE

Situation thérapeutique : Métastatique ou localement avancé

Traitement :

Cadre réglementaire : RIPH3

Dernière MÀJ : 02/08/2022
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Étude prospective observationnelle de la qualité de vie dans le CPNPC TNM de stade III non résécable

Spécialité : Organes respiratoires et intrathoraciques
Localisation : C34 - Tumeur maligne des bronches et du poumon
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : OBSTINATE is an observational, prospective, national, multicentric study conducted in patients newly diagnosed with an unresectable stage III NSCLC (with exclusion of early stages NSCLC classified to pathological stage III).

OBSTINATE is a study planned to include 450 patients between 50 to 70 GFPC-affiliates or GFPC-associated centers approximately. All centers are located in France. The participating Site Investigators will be treating physicians within one of the participating centers.

After screening for eligibility checks, patients will receive the Patient Information Note from the Site Investigators. This Patient information Note will describe the study purpose and modalities. Patients who meet the eligibility criteria and do not oppose to data collection will be enrolled. The schedule of the medical visits in the study center will depend on the patient and his/her routine clinical care Protocol-relevant data will be collected by the treating physician within each center, for up to 5 years following the last patient's enrollment in the study.

Patients included in the study will complete the self-assess questionnaires at enrollment and during routine care follow-up, according to pre-specified data collection schedule.

Usual practices or modalities of follow-up of patients will remain unchanged compared to the current clinical practice as the study is designed to provide descriptive summary information.

Phase : NA

Stade : Localisé

1
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 : • Pathological confirmation of NSCLC obtained from a tumor cytology or biopsy
• Treatment-naïve unresectable TNM stage III NSCLC (according to the 8th TNM IASLC edition). Of note, unresectability could be due to either functional limitation or anatomical extension of the tumor.
• Patient willing and able to complete collection of data via self-assessment questionnaires
• Patient without any local or systemic anti-neoplastic treatment are eligible (palliative symptomatic radiotherapy is considered best supportive care)
• Patients participating in other interventional or non-interventional studies can be included.

Critères de non-inclusion : • Early stage NSCLC initially treated locally (surgery or other) and classified as pathological TNM stage III (according to the 8th TNM IASLC edition)
• At the treating physician's discretion, patient not eligible physically or psychologically to be included in a clinical trial
• Inability to read and/or fill out self-assessment questionnaires
• Patient unable to express opposition to data collection
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT05049044
Promoteur :
GFPC GROUPE FRANCAIS DE PNEUMO-CANCEROLOGIE
Type de sponsor : Institutionnel
84 AV DE LA REPUBLIQUE
63000 CLERMONT FERRAND

Coordonnateur :
Charles RICORDEL
Charles.RICORDEL@chu-rennes.fr
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
CHI Elbeuf Louviers - Rue du Dr Villers - 76410 ST AUBIN LES ELBEUF

Investigateur :
Dr Pierre Alexandre HAUSS

TEC / ARC / IDE :
Nadjet BENOAURET
nbenouaret@
onconormandie.fr
0665.59.12.64

Statut de l'essai : OUVERT

MAJ : 08/10/2021

Centre investigateur :
CHU de Rouen - 1 Rue de Germont - 76000 ROUEN

Investigateur :
Dr Florian GUISIER

TEC / ARC / IDE :
Cathie LAVAULT
cathie.lavault@
chu-rouen.fr

Statut de l'essai : OUVERT

MAJ : 20/10/2021