Head and Neck CancersBIOFACE PASSNCT06771336
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
An observational study of Head and Neck Cancers, run by University Hospital, Toulouse at 9 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancers
- What is being tested?
- Questionnaires
- Type of treatment
- Pill or oral medicine
- How many people
- 200 participants
- Where
- 9 sitesFrance
- Study dates
- 3 Sep 2025to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 12Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Camille Dumon contact
9 sites in 1 country
France9 sites, 9 recruiting
- Not yet recruiting
University hospital of Amiens- Picardie
Amiens, 80054
Sylvie Testelin
- Not yet recruiting
University hospital of Lille
Lille, 59037
François Mouawad
- Not yet recruiting
Hospices Civils de Lyon
Lyon, 69004
Pierre PHILOUZE
- Not yet recruiting
University hospital of Montpellier
Montpellier, 34090
Marie De Boutray
- Not yet recruiting
University hospital of Nantes
Nantes, 44093
Florent Espitalier
- Not yet recruiting
Centre Antoine Lacassagne
Nice, 06189
Alexandre Bozec
- Not yet recruiting
University hospital of Rouen
Rouen, 76000
Sophie Deneuve
- Recruiting
University hospital of Toulouse
Toulouse, 31059
Agnès Dupret-Bories
Agnès Dupret-Bories
- Not yet recruiting
Institut Gustave Roussy
Villejuif, 94805
Nadia Benmoussa- Rebido
About this study
Official title: 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.
Read the 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.
- Conditions
- Head and Neck Cancers
- Being tested
- Questionnaires
- Keywords
- Mandibullar or maxillar reconstruction, Care pathway, Free bone flap, Medico-economic study
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Quality of life questionnaires, questionnaires for assessing functional results, micro-costing questionnaire, informal support assessment questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start3 Sep 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancersStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnès DUPRET-BORIES, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771336
- Sponsor's protocol ID
- RC31/24/0307
- Other IDs
- 2024-A01597-40
- Acronym
- BIOFACE PASS
- Status last verified
- Sep 2025
- First submitted
- 7 Jan 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06771336
- Acronym / sponsor ID
- BIOFACE PASS / RC31/24/0307
- Conditions
- Head and Neck Cancers
- Keywords
- Mandibullar or maxillar reconstruction, Care pathway, Free bone flap, Medico-economic study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with oral cavity cancer or maxillary and/or oropharynx cancer | – | Other: QuestionnairesPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesQuality of life questionnaires, questionnaires for assessing functional results, micro-costing questionnaire, informal support assessment questionnaires | Other | Patients with oral cavity cancer or maxillary and/or oropharynx cancer |
Primary outcome
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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
Related trials for Head and Neck Cancers
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Camille Dumon contact
Agnès DUPRET-BORIES principal investigator
University Hospital, Toulouse
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancers, run by University Hospital, Toulouse at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Agnès DUPRET-BORIES (531156014 ext. +33, dupretbories.a@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.