PROspective Master-protocol for Evaluation of Systemic THErapeutics in Elderly

Status: Recruiting
Location: See all (41) locations...
Intervention Type: Genetic, Other, Procedure
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The objective of the study is to prospectively generate real-life data in patients aged ≥70 years treated in first line for a thoracic tumor (Non-Small-Cell Lung Carcinoma) according to best standard of care as defined by the European Society for Medical Oncology (ESMO). This cohort will aim to: * characterize participants in terms of geriatrics, biology and carcinology * describe the treatment modalities by stage, as well as the results in terms of efficacy, safety and impact on quality of life. At the same time, exploratory sub-cohorts will be identified including participants treated uniformly with the same molecule, and/or the same innovative strategy. Participants will be followed in accordance with investigator's usual clinical practice at the corresponding site. They will be asked to: * visit the clinic as per physician's request for checkups and tests for assessing general condition and clinical efficacy and tolerance of current treatment. * perform the necessary regular para-clinical examinations (lab testing, imaging, re-biopsy). * provide blood samples for bio-bank repository * perform assessments specific to older adults * answer three quality of life questionnaires

Eligibility
Participation Requirements
Sex: All
Minimum Age: 70
Healthy Volunteers: f
View:

• Patient ≥70 years

• Non-small-cell lung cancer for which the multidisciplinary consultation required systemic treatment regardless of Tumor-Node-Metastasis (TNM) stage

• Patient naïve to systemic anticancer treatment for bronchial neoplasia

• Patient covered by social security

• Patient eligible for systemic treatment

• Systemic treatment with marketing authorization in the indication, available in routine care early access or compassionate access.

• Patient able to understand the protocol

• Patient not opposed to the collection of data concerning him/her

• Signature of study consent form.

Locations
Other Locations
France
CH du Pays d Aix
RECRUITING
Aix-en-provence
Hôpital Henri Duffaut
RECRUITING
Avignon
Institut du Cancer d'Avignon
NOT_YET_RECRUITING
Avignon
CH Bastia
NOT_YET_RECRUITING
Bastia
Oncologie Thoracique Hôpital Morvan
RECRUITING
Brest
Pneumologie Centre François Baclesse
NOT_YET_RECRUITING
Caen
CH Métropole-Savoie
RECRUITING
Chambéry
Centre Hospitalier du Cotentin
NOT_YET_RECRUITING
Cherbourg
CHU Hôpital Montpied
NOT_YET_RECRUITING
Clermont-ferrand
Pneumologie Hospices Civils de Colmar
RECRUITING
Colmar
Pneumologie CHI Creteil
RECRUITING
Créteil
CH Elbeuf
RECRUITING
Elbeuf
Polyclinique de Blois
NOT_YET_RECRUITING
La Chaussée-saint-victor
CHD Les Oudairies
RECRUITING
La Roche-sur-yon
CH La Rochelle
NOT_YET_RECRUITING
La Rochelle
Hôpital A. Mignot
RECRUITING
Le Chesnay
Hôpital Robert Boulin
RECRUITING
Libourne
CHU Dupuytren
RECRUITING
Limoges
Hôpital de la Vallée - Service Pneumologie
NOT_YET_RECRUITING
Longjumeau
Centre Léon Bérard
NOT_YET_RECRUITING
Lyon
Hôpital Européen de Marseille
NOT_YET_RECRUITING
Marseille
Oncologie Thoracique Hôpital Nord
RECRUITING
Marseille
GHEF Site de Meaux
RECRUITING
Meaux
Centre d Oncologie de Gentilly
RECRUITING
Nancy
Pneumologie CHR
NOT_YET_RECRUITING
Orléans
Pneumologie Hôpital Cochin
NOT_YET_RECRUITING
Paris
Pneumologie Hôpital Tenon
NOT_YET_RECRUITING
Paris
Cantre Catalan d Oncologie
NOT_YET_RECRUITING
Perpignan
CH Annecy Genevois
RECRUITING
Pringy
Pneumologie CHI Quimper
RECRUITING
Quimper
CHU Hôpital Ponchailloux
NOT_YET_RECRUITING
Rennes
Pneumologie Hôpital Charles Nicolle
NOT_YET_RECRUITING
Rouen
Pneumologie CHU Felix Guyon
NOT_YET_RECRUITING
Saint-denis
Pneumologie CHU St Etienne
RECRUITING
Saint-etienne
Clinique Mutualiste
RECRUITING
Saint-nazaire
CHU de la Réunion
NOT_YET_RECRUITING
Saint-pierre
CLCC Paul Strauss
NOT_YET_RECRUITING
Strasbourg
CHITS Toulon Sainte Musse
RECRUITING
Toulon
Hôpital d'Instruction des Armées Saint-Anne
RECRUITING
Toulon
Oncologie CHBA
RECRUITING
Vannes
Hôpital Nord OUest
RECRUITING
Villefranche-sur-saône
Contact Information
Primary
Romain CORRE, Medical Doctor
romain.corre@ch-cornouaille.fr
+330298526404
Backup
Soizic FERLANDIN
soizic_ferlandin@yahoo.fr
+330663224789
Time Frame
Start Date: 2024-09-26
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 500
Treatments
Other: Real world cohort of NSCLC older adults patients
Cohort of patients ≥70 years of age with NSCLC treated in first line therapy for thoracic tumors according to ESMO-referenced therapeutic standards or according to an innovative molecule and/or strategy.~An optional biobank based on blood samples taken during the screening phase prior to the first administration of systemic treatment will be collected. Sampling of tumoral materials will be collected prior to study participation and send for central reading.~Patients will be asked to come at the hospital for their regular visits as per site current practice and to complete three quality of life questionnaires (EORTC QLQ-F17; QLQ-LC13; QLQ-ELD14).
Sponsors
Leads: Groupe Francais De Pneumo-Cancerologie

This content was sourced from clinicaltrials.gov