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 (BIOFACE PASS)

Standard of Care Pathways Evaluation of Patients Treated for Facial Reconstruction After Surgery for Head and Neck Cancer, Using the Conventional Technique (Free Bone Flap): a Medico-economic Study

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancers
• Intervention / Treatment: Other: Questionnaires

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Agnès DUPRET-BORIES; Phone Number: +33 531156014; Email: dupretbories.a@chu-toulouse.fr
• Study Contact Backup: Name: Camille Dumon

Study Locations

• France
  • Amiens, France, 80054
    • Not yet recruiting
    • University hospital of Amiens- Picardie
    • Contact: Sylvie Testelin
  • Lille, France, 59037
    • Not yet recruiting
    • University Hospital of Lille
    • Contact: François Mouawad
  • Lyon, France, 69004
    • Not yet recruiting
    • Hospices Civils de Lyon
    • Contact: Pierre PHILOUZE
  • Montpellier, France, 34090
    • Not yet recruiting
    • University Hospital of Montpellier
    • Contact: Marie De Boutray
  • Nantes, France, 44093
    • Not yet recruiting
    • University Hospital of Nantes
    • Contact: Florent Espitalier
  • Nice, France, 06189
    • Not yet recruiting
    • Centre Antoine Lacassagne
    • Contact: Alexandre Bozec
  • Rouen, France, 76000
    • Not yet recruiting
    • University Hospital of Rouen
    • Contact: Sophie Deneuve
  • Toulouse, France, 31059
    • Recruiting
    • University Hospital of Toulouse
    • Principal Investigator: Agnès Dupret-Bories
    • Contact: Agnès Dupret-Bories
  • Villejuif, France, 94805
    • Not yet recruiting
    • Institut Gustave Roussy
    • Contact: Nadia Benmoussa- Rebido

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Questionnaires; Quality of life questionnaires, questionnaires for assessing functional results, micro-costing questionnaire, informal support assessment questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Agnès DUPRET-BORIES, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: January 7, 2025
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): January 13, 2025

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Medico-economic study; Care pathway; Free bone flap; Mandibullar or maxillar reconstruction
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: RC31/24/0307; 2024-A01597-40 (Other Identifier: Agence National de Sécurité du Médicament)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No