Nose CancerCERNASNCT07674030
Functional and Aesthetic Comparison of Surgical Nasal Reconstruction Versus Nasal Prosthesis (Epithesis) After Total or Subtotal Nasal Amputation
An observational study of Nose Cancer and Rhinectomy, run by Hôpital NOVO at 4 sites in France.
Trial summary
CERNAS is a prospective, multicenter, non-interventional study comparing the functional and aesthetic outcomes of two rehabilitation strategies after total or subtotal nasal amputation: surgical reconstruction (primarily paramedian forehead flap or free flap) versus nasal epithesis (prosthesis). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nose Cancer, Rhinectomy
- What is being tested?
- SCHNOS score
- How many people
- 20 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Jul 2026to 30 Jan 2027
- 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: Patient who has undergone surgical or prosthetic nasal reconstruction following a total or subtotal nasal amputation.
Who may be able to join
- Patients aged 18 years or older
- Patients who have undergone total or subtotal nasal amputation (defined as loss of at least three nasal subunits, or of two subunits including the dorsum) and who have been rehabilitated either by surgical reconstruction or by nasal epithesis for more than one year
Who cannot join
- Ongoing tumour progression or tumour recurrence
- Non-French-speaking patients
- Patients under legal protection measures (guardianship, legal safeguarding, limited or full legal incapacity)
- Patients unlikely to cooperate with the study (e.g. presenting with a psychiatric disorder)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Khaled AL TABAA, Doctor contact
France4 sites
CHU de Caen
Caen, 14033
Maxime HUMBERT, Doctor
Hôpital LARIBOISIERE
Paris, 75010
Benjamin VERILLAUD, Professor, 0149958061, benjamin.verillaud@aphp.fr
Benjamin VERILLAUD, Professor
Groupe Hospitalier Paris St Joseph
Paris, 75014
Vincent BEDARIDA, Doctor
Hôpital NOVO
Pontoise
Laureline DESABRES, Doctor, 01 30 75 40 40, laureline.desabres@ght-novo.fr
Laureline DESABRES, Doctor
About this study
Official title: Comparison of Epithesis and Surgical Nasal Reconstruction Using the SCHNOS Score
CERNAS is a prospective, multicenter, non-interventional study comparing the functional and aesthetic outcomes of two rehabilitation strategies after total or subtotal nasal amputation: surgical reconstruction (primarily paramedian forehead flap or free flap) versus nasal epithesis (prosthesis). Patients who have undergone either rehabilitation at least one year prior to enrolment will be invited to complete the validated French version of the SCHNOS (Standardized Cosmesis and Health Nasal Outcomes Survey) questionnaire. The study aims to provide an objective, patient-reported comparison of these two options to guide future clinical decision-making.
Read the detailed description
Total or subtotal nasal amputation - defined as loss of at least three nasal subunits, or two subunits including the dorsum - results in major aesthetic and functional consequences with a significant impact on quality of life and social reintegration. Currently, two main rehabilitation approaches exist: surgical reconstruction (paramedian forehead flap as the gold standard, or free flaps such as the radial forearm free flap for larger defects) and nasal epithesis (implant-retained or adhesive prosthesis).
The choice between these techniques is often guided by the surgeon's experience and patient preference, in the absence of clear consensus, as very few studies have directly compared both options using standardised, patient-reported outcome measures.
The primary objective of this study is to compare functional and aesthetic outcomes between surgical reconstruction and epithesis groups using the SCHNOS questionnaire validated in French. Secondary objectives include comparison of subgroups by complications, comorbidities, patient profile, and identification of patients who switched rehabilitation modality.
Eligible patients will be identified via medical records by investigators at each participating centre. Those meeting inclusion criteria will be contacted by phone and then sent the information letter and questionnaire by mail or email. They may complete the questionnaire in paper form or via the secure Microsoft Forms platform. Questionnaire data will be exported to a centralised, password-protected Excel database for statistical analysis.
- Conditions
- Nose Cancer, Rhinectomy
- Being tested
- SCHNOS score
- Keywords
- Total rhinectomy, Nasal reconstruction, Nasal prosthesis, SCHNOS, Nasal amputation, Quality of life, Free flap, Forehead flap
- Medical subject headings
- Nose Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCHNOS scoreOther
Total score on the validated French version of the SCHNOS (Standardized Cosmesis and Health Nasal Outcomes Survey) questionnaire, comparing surgical reconstruction versus epithesis groups after total or subtotal nasal amputation.
| Study group | Role | What they receive |
|---|---|---|
| Surgical Reconstruction | Patient who has had nasal reconstruction Receives: Other: SCHNOS score | |
| Nasal Epithesis | Patient who has had a nasal prosthesis Receives: Other: SCHNOS score |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCHNOS total score
Total score on the validated French version of the SCHNOS (Standardized Cosmesis and Health Nasal Outcomes Survey) questionnaire, comparing surgical reconstruction versus epithesis groups after total or subtotal nasal amputation.
Measured: Single assessment at inclusion (at least 1 year after nasal reconstruction or epithesis placement)
Secondary outcomes (3)
Subgroup comparison by complications and comorbidities
Comparison of SCHNOS scores between subgroups defined by complications, comorbidities, and patient profile (age, sex, aetiology of amputation, treatment history).
Measured: Single assessment at inclusion
Description of Clinical Profiles
Subgroup analysis of the profiles of patients who opted to change their rehabilitation treatment
Measured: Single assessment at inclusion
Benefit-risk balance of each rehabilitation technique
Comparative analysis of each technique based on implementation modalities, time to rehabilitation, complications, and reversibility.
Measured: Single assessment at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion2 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nose CancerStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laureline DESABRES, Doctor, Principal investigator, Hôpital NOVOBenjamin VERILLAUD, Pr, Principal investigator, Hôpital LARIBOISIEREVincent BEDARIDA, Doctor, Principal investigator, Groupe Hospitalier Paris St JosephMaxime HUMBERT, Doctor, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674030
- Sponsor's protocol ID
- 2026-A00866-45
- Other IDs
- CHRD0826
- Acronym
- CERNAS
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Epithesis and Surgical Nasal Reconstruction Using the SCHNOS Score
- ClinicalTrials.gov ID
- NCT07674030
- Acronym / sponsor ID
- CERNAS / 2026-A00866-45
- Conditions
- Nose Cancer, Rhinectomy
- Keywords
- Total rhinectomy, Nasal reconstruction, Nasal prosthesis, SCHNOS, Nasal amputation, Quality of life, Free flap, Forehead flap
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 2 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 29 Jun 2026 (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.
CERNAS is a prospective, multicenter, non-interventional study comparing the functional and aesthetic outcomes of two rehabilitation strategies after total or subtotal nasal amputation: surgical reconstruction (primarily paramedian forehead flap or free flap) versus nasal epithesis (prosthesis). Patients who have undergone either rehabilitation at least one year prior to enrolment will be invited to complete the validated French version of the SCHNOS (Standardized Cosmesis and Health Nasal Outcomes Survey) questionnaire. The study aims to provide an objective, patient-reported comparison of these two options to guide future clinical decision-making.
Detailed description
Total or subtotal nasal amputation - defined as loss of at least three nasal subunits, or two subunits including the dorsum - results in major aesthetic and functional consequences with a significant impact on quality of life and social reintegration. Currently, two main rehabilitation approaches exist: surgical reconstruction (paramedian forehead flap as the gold standard, or free flaps such as the radial forearm free flap for larger defects) and nasal epithesis (implant-retained or adhesive prosthesis).
The choice between these techniques is often guided by the surgeon's experience and patient preference, in the absence of clear consensus, as very few studies have directly compared both options using standardised, patient-reported outcome measures.
The primary objective of this study is to compare functional and aesthetic outcomes between surgical reconstruction and epithesis groups using the SCHNOS questionnaire validated in French. Secondary objectives include comparison of subgroups by complications, comorbidities, patient profile, and identification of patients who switched rehabilitation modality.
Eligible patients will be identified via medical records by investigators at each participating centre. Those meeting inclusion criteria will be contacted by phone and then sent the information letter and questionnaire by mail or email. They may complete the questionnaire in paper form or via the secure Microsoft Forms platform. Questionnaire data will be exported to a centralised, password-protected Excel database for statistical analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Reconstruction | – | Other: SCHNOS scorePatient who has had nasal reconstruction |
| Nasal Epithesis | – | Other: SCHNOS scorePatient who has had a nasal prosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who has undergone surgical or prosthetic nasal reconstruction following a total or subtotal nasal amputation.
Key inclusion criteria (2 listed)
- Patients aged 18 years or older
- Patients who have undergone total or subtotal nasal amputation (defined as loss of at least three nasal subunits, or of two subunits including the dorsum) and who have been rehabilitated either by surgical reconstruction or by nasal epithesis for more than one year
Key exclusion criteria (4 listed)
- Ongoing tumour progression or tumour recurrence
- Non-French-speaking patients
- Patients under legal protection measures (guardianship, legal safeguarding, limited or full legal incapacity)
- Patients unlikely to cooperate with the study (e.g. presenting with a psychiatric disorder)
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 |
|---|---|---|
| SCHNOS scoreTotal score on the validated French version of the SCHNOS (Standardized Cosmesis and Health Nasal Outcomes Survey) questionnaire, comparing surgical reconstruction versus epithesis groups after total or subtotal nasal amputation. | Other | Nasal Epithesis, Surgical Reconstruction |
Primary outcome
SCHNOS total score
Time frame: Single assessment at inclusion (at least 1 year after nasal reconstruction or epithesis placement)
Total score on the validated French version of the SCHNOS (Standardized Cosmesis and Health Nasal Outcomes Survey) questionnaire, comparing surgical reconstruction versus epithesis groups after total or subtotal nasal amputation.
3 secondary outcomes
Subgroup comparison by complications and comorbidities
Time frame: Single assessment at inclusion
Description of Clinical Profiles
Time frame: Single assessment at inclusion
Benefit-risk balance of each rehabilitation technique
Time frame: Single assessment at inclusion
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 1 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Khaled AL TABAA, Doctor contact
Laureline DESABRES, Doctor principal investigator
Hôpital NOVO
Benjamin VERILLAUD, Pr principal investigator
Hôpital LARIBOISIERE
Vincent BEDARIDA, Doctor principal investigator
Groupe Hospitalier Paris St Joseph
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nose Cancer and Rhinectomy, run by Hôpital NOVO at 4 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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 Laureline DESABRES, Doctor (01 30 75 40 40, laureline.desabres@ght-novo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCHNOS total score (time frame: Single assessment at inclusion (at least 1 year after nasal reconstruction or epithesis placement)). 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 1 Jul 2026.