Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT05272358 Statut inconnu

Titre

Economic Evaluation of Early Management of Sarcoma Patients by the Sarcoma Reference Network (NETSARC), Exploration of Organisational and Financial Constraints (OPTISARC)

Type

Observational

Pathologie

Sarcomes

Phase

Promoteur

Centre Leon Berard (Voir sur ClinicalTrials)

Date de début

février 2021

Date de fin

février 2024

Dernière mise à jour

29 juin 2024

Résumé

The aim of this project is to (1) evaluate the efficiency of early management of sarcoma patients by the sarcoma referral network (NETSARC) vs. outside the network; (2) measure the budgetary impact of the generalization of the most cost-effective strategy across the country; (3) identify the organizational and financial constraints likely to hinder the generalization of the most cost-effective strategy and propose solutions, and finally (4) analyse the budgetary impact of a generalization of sarcoma patient care by the reference network by integrating the organizational and financial solutions proposed. The study relies on an exhaustive national cohort of all sarcoma patients who underwent primary tumor surgery for the year 2013. Patients will be allocated to four distinct strategies, each representing a different management of sarcoma patients who had a sarcoma-specialized multidisciplinary tumor board (MDTB) before the initial surgery and complete initial management in the network (strategy 1); patients who had a sarcoma-specialized MDTB before the initial surgery and initial management outside the network (strategy 2); patients who had a sarcoma-specialized MDTB after initial surgery and initial management outside the network (strategy 3); patients who had an initial management outside the network, without sarcoma-specialized MDTB neither before nor after the initial surgery (strategy 4). Matching of the National Health Data System (SNDS) and the NETSARC databases made it possible to include 2431 patients in the study. These databases will allow to obtain information on patients, estimate overall survival and identify healthcare consumption, which will be useful in achieving study's objectives.

Détail

Voir le détail Introduction Sarcomas are a large family of rare and heterogeneous tumors. As a consequence, their diagnosis and management are difficult and complex, which can lead to misdiagnosis and suboptimal patient management. Thus, in 2009, the National Cancer Institute (INCa) and the "Direction Générale de l'Offre de Soins" (DGOS) supported the creation of a sarcoma reference network (NETSARC) with the aim to guarantee optimal care for sarcoma patients. Numerous studies show that initial patients' management in the sarcoma referral network reduces the risk of death and relapse. However, the proportion of sarcoma patients initially managed within the referral network is still too low today. The aim of this project is to (1) evaluate the efficiency of early management of sarcoma patients by the sarcoma referral network vs. outside the network; (2) measure the budgetary impact of the generalization of the most cost-effective strategy across the country; (3) identify the organizational and financial constraints likely to hinder the generalization of the most cost-effective strategy and propose solutions, and finally (4) analyses the budgetary impact of a generalization of sarcoma patient care by the reference network by integrating the organizational and financial solutions proposed. Methods and analysis The study relies on an exhaustive national cohort of all sarcoma patients (ICD code 10 C49, C48 or C40-41) who underwent primary tumor surgery for the year 2013. Patients will be allocated to four distinct strategies, each representing a different management of sarcoma patients: patients who had a sarcoma-specialized multidisciplinary tumor board (MDTB) before the initial surgery and complete initial management in the network (strategy 1); patients who had a sarcoma-specialized MDTB before the initial surgery and initial management outside the network (strategy 2); patients who had a sarcoma-specialized MDTB after initial surgery and initial management outside the network (strategy 3); patients who had an initial management outside the network, without sarcoma-specialized MDTB neither before nor after the initial surgery (strategy 4). Matching of the National Health Data System (SNDS) and the NETSARC databases made it possible to include 2431 patients in the study. These databases will allow to obtain information on patients, estimate overall survival and identify healthcare consumption, which will be useful to achieve study's objectives. The evaluation of early management of operable sarcoma patients by the sarcoma reference network vs. outside the network will be based on three approaches which are both distinct and complementary in terms of decision support. (1) Firstly, an efficiency assessment based on a cost-effectiveness analysis (CEA) and a cost-utility analysis (CUA) will be carried out. The short-term CEA will use the Incremental Cost-Effectiveness Ratio (ICER) expressed as cost per life year gained, while the long-term CUA will use the ICER expressed as cost per quality-adjusted life year (QALY) gained. The efficiency analysis will be complemented by a Budget Impact Analysis (BIA) based on an estimate of the additional and avoided costs induced by the generalization of the most cost-effective strategy determined in the previous steps. (2) Next, an organizational evaluation focusing on a flow analysis will be carried out. (3) Finally, an innovative financing model will be developed to encourage inter-center cooperation. Ethics and dissemination The OPTISARC project will be conducted in accordance with the ethical principles of the latest version of the Declaration of Helsinki developed by the World Medical Association (WMA). This study falls within the framework of research not involving the human person, study or health assessment (RNIPH) and will be conducted in accordance with the French and European laws and regulations in force, as well as any other applicable guidelines. This Project has obtained a favorable opinion from the "Comité d'Expertise pour les Recherches, les Etudes et les Evaluations dans le domaine de la Santé" (CEREES) and an authorization from the "Comité National Informatique et Liberté" (CNIL) allowing the access to SNDS data (DCIR and PMSI) from 2013 to 2018. Fermer le détail

Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Cochin	Philippe Anract, PU-PH	En recrutement IDF	Contact (sur clinicalTrials)
CLCC INSTITUT CURIE	Sophie Piperno-Neumann, MD	En recrutement IDF	Contact (sur clinicalTrials)
CLCC INSTITUT GUSTAVE ROUSSY	Axel Le Cesne, Prof.	En recrutement IDF	Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre Antoine Lacassagne - 06000 - Nice - France	Esma Saada, MD	En recrutement	Contact (sur clinicalTrials)
Centre François Baclesse - 14000 - Caen - France	Sharmini Varatharajah, MD	En recrutement	Contact (sur clinicalTrials)
Centre Georges François Leclerc - 21000 - Dijon - France	Sylvain Causeret, MD	En recrutement	Contact (sur clinicalTrials)
Centre Henri Becquerel - 76000 - Rouen - France	Cécile Guillemet, MD	En recrutement	Contact (sur clinicalTrials)
Centre Jean Perrin - 63000 - Clermont-Ferrand - France	Pascale Dubray-Longeras, MD	En recrutement	Contact (sur clinicalTrials)
Centre Leon Berard - 69008 - Lyon - France	Jean-Yves Blay, PU-PH	En recrutement	Contact (sur clinicalTrials)
Centre Oscar Lambret - 59000 - Lille - France	Nicolas PENEL, PU-PH	En recrutement	Contact (sur clinicalTrials)
CHU Dupuytren - 87000 - Limoges - France	Fabrice Fiorenza, MD	En recrutement	Contact (sur clinicalTrials)
CHU Jean Minjoz - 25000 - Besançon - France	Loic Chaigneau, MD	En recrutement	Contact (sur clinicalTrials)
CHU Pontchaillou - 35000 - Rennes - France	Mickael Ropars, PU-PH	En recrutement	Contact (sur clinicalTrials)
CHU Saint-Louis - 75000 - Paris - France	Céleste Lebbé, PU-PH	En recrutement	Contact (sur clinicalTrials)
CHU Saint-Pierre - 97000 - La Réunion - France	Jean-Christophe Ruzic, MD	En recrutement	Contact (sur clinicalTrials)
CHU Timone - 13000 - Marseille - France	Florence Duffaud, PU-PH	En recrutement	Contact (sur clinicalTrials)
CHU Trousseau - 37000 - Tours - France	Philippe Rosset, PU-PH	En recrutement	Contact (sur clinicalTrials)
ICM Val d'Aurelle - 34000 - Montpellier - France	Sébastien Carrère, MD	En recrutement	Contact (sur clinicalTrials)
Institut Bergonié - 33000 - Bordeaux - France	Antoine Italiano, PU-PH	En recrutement	Contact (sur clinicalTrials)
Institut de Cancérologie CHU Hautepierre - 67000 - Strasbourg - France	Jean-Emmanuel Kurtz, PU-PH	En recrutement	Contact (sur clinicalTrials)
Institut de cancérologie de Lorraine - 54000 - Nancy - France	Maria Rios, MD	En recrutement	Contact (sur clinicalTrials)
Institut de Cancérologie de l'Ouest - 44800 - Nantes - France	Emmanuelle Bompas, MD	En recrutement	Contact (sur clinicalTrials)
Institut jean Godinot - 51000 - Reims - France	Pauline Soibinet-Oudot, MD	En recrutement	Contact (sur clinicalTrials)
Institut Paoli Calmettes - 13000 - Marseille - France	François Bertucci, PU-PH	En recrutement	Contact (sur clinicalTrials)
IUCT Institut Claudius Régaud - 31000 - Toulouse - France	Christine Chevreau, MD	En recrutement	Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

Inclusion Criteria:

- Sarcoma diagnosis between 01/01/2013 and 31/12/2013

- International Classification of Diseases (ICD) code 10: C49 Malignant neoplasm of
other connective and soft tissue, or C48 Malignant neoplasm of retroperitoneum and
peritoneum, or C40-41 Malignant neoplasm of bone and articular cartilage of limbs)

- Surgery of the primary tumour.

Critère de non inclusion

- Gastro intestinal stromal tumour

- Diagnosis not confirmed by the a second histological review

NCT05272358 - Economic Evaluation of Early Management of Sarcoma Patients by the Sarcoma Reference Network (NETSARC), Exploration of Organisational and Financial Constraints (OPTISARC)

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