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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01597-40 | Other Identifier | Agence National de Sécurité du Médicament |
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The purpose of this study is to describe the standard of care pathway of patients treated by free bone flap for facial mandibullar or maxillar reconstruction after surgery for head and neck cancers.
Curative management of head and neck cancers frequently requires an interrupting mandibulectomy or maxillectomy. Surgery may involve resection of anatomical structures such as jaw or maxilla. The use of free vascularized fibula or scapula flap is the "gold standard" for mandibular and maxillary reconstruction but remains suboptimal as resulting in difficulty in speaking, swallowing, and disfigurement.
The BIOFACE project, funded by "Appel à Projet -Recherche Hospitalo-Universitaire en santé (RHU)" number 6 France 2023, aims to develop a new biomaterials based device to reconstruct these structure after surgery. In addition to the clinical benefits, this project aims to demonstrate the medico-economic benefits of the BIOFACE solution. Therefore, the Bioface PASS study has been designed to describe standard of care pathways of patients treated by free bone flap for facial reconstruction after surgery for head and neck cancer. Direct medical and non-medical costs, and daily allowance 12 months after the end of treatment, and quality of life will be recorded at the inclusion, 3 and 12 months.
From the hospital perspectives, production costs will be recorded using the micro-costing approach.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with oral cavity cancer or maxillary and/or oropharynx cancer | Patients with oral cavity cancer or maxillary and/or oropharynx cancer eligible for treatment by surgery requiring a mandibulectomy or segmental maxillectomy and having a free bone flap for facial reconstruction. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Other | Quality of life questionnaires, questionnaires for assessing functional results, micro-costing questionnaire, informal support assessment questionnaires |
|
| Measure | Description | Time Frame |
|---|---|---|
| Description of the standard of care pathway of patients treated by free bone flap for facial mandibullar or maxillar reconstruction after surgery for head and neck cancers | The primary outcome measure is a composite endpoint consisting of the description of care pathways based on care consumption (scheduled and unscheduled hospitalizations and consultations, medical procedures and medications). The study of pathways will take into account data from the National Health Data System (i.e. healthcare consumption). These data will then be aggregated and structured to form time sequences representing the care pathways (and classes of care pathways) of patients using the optimal matching method. These sequences will include several medical events such as consultations, treatments, hospitalizations for example. This will provide us with a simplified but detailed representation of care trajectories. The individual care sequences thus constructed will allow us to carry out sequence analyzes aimed at creating patient clusters. | 12 months |
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Inclusion Criteria:
Non-inclusion Criteria:
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Participation in the protocol will be offered to all patients meeting the eligibility criteria during the 3-year inclusion period.
It is planned to include 200 operated patients, including 50 treated by maxillectomy and 150 treated by mandibulectomy.
Nine French cancer centers and university hospitals will participate in the project: the University Hospitals of Toulouse, Amiens, Rouen, Lille, Montpellier, Nantes, the Gustave Roussy Institute, the Antoine Lacassagne Center (Nice) and the Hospices Civil de Lyon.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agnès DUPRET-BORIES | Contact | 531156014 | +33 | dupretbories.a@chu-toulouse.fr |
| Camille Dumon | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Agnès DUPRET-BORIES | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University hospital of Amiens- Picardie | Not yet recruiting | Amiens | 80054 | France |
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| University hospital of Lille | Not yet recruiting | Lille | 59037 | France |
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| Hospices Civils de Lyon | Not yet recruiting | Lyon | 69004 | France |
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| University hospital of Montpellier | Not yet recruiting | Montpellier | 34090 | France |
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| University hospital of Nantes | Not yet recruiting | Nantes | 44093 | France |
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| Centre Antoine Lacassagne | Not yet recruiting | Nice | 06189 | France |
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| University hospital of Rouen | Not yet recruiting | Rouen | 76000 | France |
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| University hospital of Toulouse | Recruiting | Toulouse | 31059 | France |
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| Institut Gustave Roussy | Not yet recruiting | Villejuif | 94805 | France |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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