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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

None

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Questionnaires

    Other intervention

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Patients with oral cavity cancer or maxillary and/or oropharynx cancer1 intervention

Trial outcomes

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.

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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