Biomedical Innovation for Facial Bone Reconstruction in Oncology: BIOFACE PASS a Medico-economic Study Describing the Standard Pathway of Patients Treated by Free Bone Flap

Not yet recruiting

• Conditions: Head and Neck Cancers

• Registration Number: NCT06771336
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-10
• Last Update Submitted: 2025-01-10
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Study Start: 2025-02
• Primary Completion: 2029-05
• Study Completion: 2029-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patient 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.
• Patient whose disease is classified Stage cT4a, N0 to N3, M0
• Treatment with a feasible curative aim (no contraindication to optimal treatment such as surgery or chemotherapy at a curative dose)
• Age greater than or equal to 18 years
• Patient affiliated to a Social Security scheme in France
• Patient having given written informed consent

Non-inclusion Criteria:

• Patient having any situation considered by the doctor as a reason for non-inclusion such as stenosis of the leg tripod not allowing reconstruction by fibula, one or more comorbidity(s) not allowing reconstruction by free bone flap or making this reconstruction too much risk
• Patient having had previous radiotherapy
• Patient with severe coagulation disorders
• Patients deprived of liberty or under legal protection regime (curatorship and guardianship, safeguard of justice)

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	12 months	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.

Trial Locations

Locations (9)

University hospital of Amiens- Picardie; 🇫🇷 Amiens, France

University hospital of Lille; 🇫🇷 Lille, France

Hospices Civils de Lyon; 🇫🇷 Lyon, France

University hospital of Montpellier; 🇫🇷 Montpellier, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

University hospital of Nantes; 🇫🇷 Nantes, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

University hospital of Rouen; 🇫🇷 Rouen, France

University hospital of Toulouse; 🇫🇷 Toulouse, France