Economic Evaluation of Sarcoma Patients Management in France
NCT ID: NCT05272358
Last Updated: 2022-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2431 participants
OBSERVATIONAL
2021-02-08
2024-02-08
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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strategy 1: sarcoma MDTB before surgery and initial management in the NETSARC network
Patients who had a sarcoma-specialized multidisciplinary tumour board (MDTB) before the initial surgery and complete initial management (including surgery) in the network (also including patients who had a sarcoma-specialized MDTB after the initial surgery and complete initial management in the network) (strategy 1)
NETSARC network
MDTB and/or surgery in NETSARC network
strategy 2: sarcoma MDTB before surgery and initial management outside the NETSARC network
Patients who had a sarcoma-specialized MDTB before the initial surgery and initial management (including surgery) outside the network (strategy 2)
NETSARC network
MDTB and/or surgery in NETSARC network
strategy 3: sarcoma MDTB after surgery and initial management outside the NETSARC network
Patients who had initial management (including surgery) outside the network and a sarcoma-specialized MDTB after initial surgery (strategy 3)
NETSARC network
MDTB and/or surgery in NETSARC network
strategy 4: No sarcoma MDTB and initial management outside the NETSARC network
Patients who had an initial management (including surgery) outside the network, without sarcoma-specialized MDTB neither before nor after the initial surgery (strategy 4).
No interventions assigned to this group
Interventions
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NETSARC network
MDTB and/or surgery in NETSARC network
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Diagnosis not confirmed by the a second histological review
ALL
No
Sponsors
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Saint Etienne School of Mine
OTHER
Rennes University Hospital
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Centre Leon Berard
OTHER
Responsible Party
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Principal Investigators
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Jean-Yves Blay, PU-PH
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard
Locations
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CHU Jean Minjoz
Besançon, , France
Institut Bergonié
Bordeaux, , France
Centre François Baclesse
Caen, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Centre Georges François Leclerc
Dijon, , France
CHU Saint-Pierre
La Réunion, , France
Centre Oscar Lambret
Lille, , France
CHU Dupuytren
Limoges, , France
Centre Leon Berard
Lyon, , France
CHU Timone
Marseille, , France
Institut Paoli Calmettes
Marseille, , France
ICM Val d'Aurelle
Montpellier, , France
Institut de cancérologie de Lorraine
Nancy, , France
Institut de Cancérologie de l'Ouest
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
CHU Cochin
Paris, , France
CHU Saint-Louis
Paris, , France
Institut Curie
Paris, , France
Institut jean Godinot
Reims, , France
CHU Pontchaillou
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Institut de Cancérologie CHU Hautepierre
Strasbourg, , France
IUCT Institut Claudius Régaud
Toulouse, , France
CHU Trousseau
Tours, , France
Gustave Roussy
Villejuif, , France
Countries
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Central Contacts
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Facility Contacts
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Loic Chaigneau, MD
Role: primary
Antoine Italiano, PU-PH
Role: primary
Sharmini Varatharajah, MD
Role: primary
Pascale Dubray-Longeras, MD
Role: primary
Sylvain Causeret, MD
Role: primary
Jean-Christophe Ruzic, MD
Role: primary
Nicolas PENEL, PU-PH
Role: primary
Fabrice Fiorenza, MD
Role: primary
Jean-Yves Blay, PU-PH
Role: primary
Florence Duffaud, PU-PH
Role: primary
François Bertucci, PU-PH
Role: primary
Sébastien Carrère, MD
Role: primary
Maria Rios, MD
Role: primary
Emmanuelle Bompas, MD
Role: primary
Esma Saada, MD
Role: primary
Philippe Anract, PU-PH
Role: primary
Céleste Lebbé, PU-PH
Role: primary
Sophie Piperno-Neumann, MD
Role: primary
Pauline Soibinet-Oudot, MD
Role: primary
Mickael Ropars, PU-PH
Role: primary
Cécile Guillemet, MD
Role: primary
Jean-Emmanuel Kurtz, PU-PH
Role: primary
Christine Chevreau, MD
Role: primary
Philippe Rosset, PU-PH
Role: primary
Axel Le Cesne, Prof.
Role: primary
Other Identifiers
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OPTISARC
Identifier Type: -
Identifier Source: org_study_id
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