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

NCT06771336 | Recruiting

• 2 other identifiers: RC31/24/03072024-A01597-40
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 9

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.

Conditions

Head and Neck Cancers

Keywords

Mandibullar or maxillar reconstruction; Care pathway; Free bone flap; Medico-economic study

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Questionnaires OTHER

Quality of life questionnaires, questionnaires for assessing functional results, micro-costing questionnaire, informal support assessment questionnaires

Patients with oral cavity cancer or maxillary and/or oropharynx cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (9)

University hospital of Amiens- Picardie

Amiens, 80054, France

NOT YET RECRUITING

University hospital of Lille

Lille, 59037, France

NOT YET RECRUITING

Hospices Civils de Lyon

Lyon, 69004, France

NOT YET RECRUITING

University hospital of Montpellier

Montpellier, 34090, France

NOT YET RECRUITING

University hospital of Nantes

Nantes, 44093, France

NOT YET RECRUITING

Centre Antoine Lacassagne

Nice, 06189, France

NOT YET RECRUITING

University hospital of Rouen

Rouen, 76000, France

NOT YET RECRUITING

University hospital of Toulouse

Toulouse, 31059, France

RECRUITING

Institut Gustave Roussy

Villejuif, 94805, France

NOT YET RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Agnès DUPRET-BORIES

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agnès DUPRET-BORIES

CONTACT

531156014; dupretbories.a@chu-toulouse.fr

Camille Dumon

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

FR (9)