CarcinomaNCT07257094
Nasal Reconstruction FACE-Q : French Validation of the Nasal Reconstruction FACE-Q Questionnaire for Reconstruction/Rehabilitation Following Nasal Skin Cancer
An observational study of Carcinoma, run by Hôpital NOVO at 9 sites in France.
Trial summary
This study aims to validate a French version of the Nasal Reconstruction FACE-Q questionnaire for patients who have undergone nasal reconstruction or prosthetic rehabilitation after surgery for nasal skin cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma
- What is being tested?
- operated patients
- How many people
- 346 participants
- Where
- 9 sitesFrance
- Study dates
- 10 Jan 2026to 30 Jul 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: Patients / Controls
Who may be able to join
- Age ≥ 18 years
- Patient who has undergone excision of a cutaneous, mucocutaneous, or vestibular nasal cancer with surgical reconstruction using a flap or prosthetic rehabilitation, performed more than 4 months ago, with stable results, and less than 3 years ago
- Patient informed of the study and not opposed to participation
- Age ≥ 65 years
- Subject informed and not opposed to participating in the study
- Subject who has never undergone facial trauma or surgery, and without major comorbidity, defined as follows:
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- No heart failure (moderate or severe heart failure, history of heart attack within the last 6 months);
- No severe chronic respiratory disease (no stage III-IV COPD, no prolonged oxygen therapy);
- No uncontrolled diabetes or associated severe complications;
- No active immunosuppressive diseases or high-dose immunosuppressive treatment;
- No unstable or severe facial dermatological conditions;
- No comorbidities seriously affecting quality of life or respiratory function (at the investigator's discretion).
Who cannot join
- Patient under anticoagulant or antiplatelet therapy Non-French-speaking patient
- Patient under legal protection (e.g., guardianship, legal safeguard) or with limited legal capacity
- Patient unlikely to cooperate with the study and/or poor anticipated compliance as judged by the investigator (including psychiatric disorders other than depressive disorder or cognitive impairment)
- Pregnant or breastfeeding woman
- CONTROL
- Non-English speaking subject
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- Subject under guardianship or legal protection, legally incompetent or with limited legal capacity
- Subject unlikely to cooperate in the study and/or anticipated low cooperation by the investigator (particularly those with psychiatric disorders other than depression or cognitive disorders)
- Pregnant or breastfeeding women
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 9 recruiting
- Not yet recruiting
CHU Caen
Caen, 14000
Maxime HUMBERT, Dr, 2 31 06 39 46, humbert-m@chu-caen.fr
- Recruiting
Centre Antoine Lacassagne
Nice, 06000
Gilles POISSONNET, Doctor, +33 4 92 03 14 38, gilles.poissonnet@nice.unicancer.fr
- Not yet recruiting
Institut Curie
Paris, 75005
Maria LESNIK, Doctor, 01 44 32 45 35, maria.lesnik@curie.fr
- Not yet recruiting
Hôpital Lariboisière (AP-HP)
Paris, 75010
Benjamin VERILLAUD, Pr, 01 42 49 80 68, benjamin.verillaud@aphp.fr
- Not yet recruiting
Hôpital Bichat (APHP)
Paris, 75018
Caroline HALIMI LEVY, Doctor, +33 1 40 25 70 44, caroline.halimi@aphp.fr
- Recruiting
Hopital Novo
Pontoise, 95300
Khaled AL TABAA, Doctor, +33 1 30 75 40 40 ext. poste 71 51), khaled.altabaa@ght-novo.fr
- Recruiting
HNIA Toulon
Toulon, 83000
Jean-Baptiste MORVAN, Pr, +33 4 83 16 25 86, jean-baptiste.morvan@sainteanne.org
- Not yet recruiting
CHU Toulouse
Toulouse, 31400
Guillaume DE BONNECAZE, Pr, 05 67 77 17 88, debonnecaze.g@chu-toulouse.fr
- Recruiting
Institut Gustave Roussy
Villejuif, 94800
Nadia BENMOUSSA REBIBO, Doctor, 01 42 11 46 03, Nadia.BENMOUSSA-REBIBO@gustaveroussy.fr
About this study
Official title: French Validation of the Nasal Reconstruction FACE-Q Questionnaire for Reconstruction/Rehabilitation Following Nasal Skin Cancer
This study aims to validate a French version of the Nasal Reconstruction FACE-Q questionnaire for patients who have undergone nasal reconstruction or prosthetic rehabilitation after surgery for nasal skin cancer. The questionnaire evaluates appearance, quality of life, and possible side effects related to the reconstruction.
The investigators hypothesize that the validated French version will provide a reliable and standardized tool to assess patient satisfaction and health-related quality of life in this context.
Read the detailed description
Nasal skin cancers often require surgical excision that can result in significant tissue loss. Treatment may involve complex surgical reconstruction or, in some cases, prosthetic rehabilitation. These procedures may have major aesthetic, functional, and psychological consequences.
FACE-Q is an internationally recognized, patient-reported outcome instrument designed to assess satisfaction with appearance, health-related quality of life, and treatment-related adverse effects. However, FACE-Q was developed and validated in English and requires cultural and linguistic adaptation for reliable use in French-speaking populations.
This non-interventional, multicenter study aims to translate and validate the relevant FACE-Q Aesthetics scales in French for patients who have undergone nasal reconstruction or prosthetic rehabilitation after skin cancer. The selected domains address facial and nasal appearance, psychosocial well-being, social function, satisfaction with outcomes, and procedure-related adverse effects.
The expected outcome is to provide a standardized and validated French-language tool that reliably evaluates these patients' satisfaction and quality of life. Such a tool may be applied in clinical practice and future comparative research to improve patient care.
- Conditions
- Carcinoma
- Being tested
- operated patients, Control
- Keywords
- Basal Cell carcinoma, Squamous Cell carcinoma, Rhinectomy, Reconstructive Surgical Procedures, Prosthesis Implantation, FACE-Q, Quality of Life
- Medical subject headings
- Carcinoma, Carcinoma, Basal Cell, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
operated patientsOther
Response to the Nasal Reconstruction FACE-Q questionnaire, which includes the following scales :
- Appearence : Face overall, nose, nostrils, skin
- Health related quality of life (HRQOL) : Early life impact, psychological, social, outcome
- Adverse effects : on the nose, on the forehead, eyebrows and scalp
- Nasal Obstruction Symptom Evaluation (NOSE)
- Short-Form-36 (SF 36)
ControlOther
Response to the Nasal Reconstruction FACE-Q questionnaire, which includes the following scales :
- Appearence : Face overall, nose, nostrils, skin impact psychological, impact social,
- SF36
| Study group | Role | What they receive |
|---|---|---|
| Operated patients | Patients with skin cancer in the nasal region who have undergone surgical reconstruction using a flap or rehabilitation using a prosthesis. Receives: Other: operated patients | |
| Control | Patients with no history of surgery or facial trauma Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric validation of the French version of Nasal Reconstruction FACE-Q
Test the acceptability, reliability, construct validity, and sensitivity to change of the questionnaire.
Measured: 7 days
Secondary outcomes (1)
Assessment of the post operative functional satisfaction
Evaluation of postoperative functional satisfaction using the Nasal Obstruction Symptom Evaluation (NOSE) questionnaire, which measures the severity of nasal breathing obstruction. Correlations will then be calculated between the NOSE and each of the FACE-Q.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start10 Jan 2026
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies 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
- 346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khaled AL TABAA, Doctor, Study director, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257094
- Sponsor's protocol ID
- 2025-A02195-44
- Other IDs
- CHRD 1424
- Status last verified
- Jul 2026
- First submitted
- 21 Nov 2025
- Last updated
- 9 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 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Validation of the Nasal Reconstruction FACE-Q Questionnaire for Reconstruction/Rehabilitation Following Nasal Skin Cancer
- ClinicalTrials.gov ID
- NCT07257094
- Acronym / sponsor ID
- 2025-A02195-44
- Conditions
- Carcinoma
- Keywords
- Basal Cell carcinoma, Squamous Cell carcinoma, Rhinectomy, Reconstructive Surgical Procedures, Prosthesis Implantation, FACE-Q, Quality of Life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 10 Jan 2026 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 2 Dec 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.
This study aims to validate a French version of the Nasal Reconstruction FACE-Q questionnaire for patients who have undergone nasal reconstruction or prosthetic rehabilitation after surgery for nasal skin cancer. The questionnaire evaluates appearance, quality of life, and possible side effects related to the reconstruction.
The investigators hypothesize that the validated French version will provide a reliable and standardized tool to assess patient satisfaction and health-related quality of life in this context.
Detailed description
Nasal skin cancers often require surgical excision that can result in significant tissue loss. Treatment may involve complex surgical reconstruction or, in some cases, prosthetic rehabilitation. These procedures may have major aesthetic, functional, and psychological consequences.
FACE-Q is an internationally recognized, patient-reported outcome instrument designed to assess satisfaction with appearance, health-related quality of life, and treatment-related adverse effects. However, FACE-Q was developed and validated in English and requires cultural and linguistic adaptation for reliable use in French-speaking populations.
This non-interventional, multicenter study aims to translate and validate the relevant FACE-Q Aesthetics scales in French for patients who have undergone nasal reconstruction or prosthetic rehabilitation after skin cancer. The selected domains address facial and nasal appearance, psychosocial well-being, social function, satisfaction with outcomes, and procedure-related adverse effects.
The expected outcome is to provide a standardized and validated French-language tool that reliably evaluates these patients' satisfaction and quality of life. Such a tool may be applied in clinical practice and future comparative research to improve patient care.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Operated patients | – | Other: operated patientsPatients with skin cancer in the nasal region who have undergone surgical reconstruction using a flap or rehabilitation using a prosthesis. |
| Control | – | Other: ControlPatients with no history of surgery or facial trauma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients / Controls
Key inclusion criteria (12 listed)
- Age ≥ 18 years
- Patient who has undergone excision of a cutaneous, mucocutaneous, or vestibular nasal cancer with surgical reconstruction using a flap or prosthetic rehabilitation, performed more than 4 months ago, with stable results, and less than 3 years ago
- Patient informed of the study and not opposed to participation
- Age ≥ 65 years
- Subject informed and not opposed to participating in the study
Key exclusion criteria (9 listed)
- Patient under anticoagulant or antiplatelet therapy Non-French-speaking patient
- Patient under legal protection (e.g., guardianship, legal safeguard) or with limited legal capacity
- Patient unlikely to cooperate with the study and/or poor anticipated compliance as judged by the investigator (including psychiatric disorders other than depressive disorder or cognitive impairment)
- Pregnant or breastfeeding woman
- CONTROL
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 |
|---|---|---|
| operated patientsResponse to the Nasal Reconstruction FACE-Q questionnaire, which includes the following scales : * Appearence : Face overall, nose, nostrils, skin * Health related quality of life (HRQOL) : Early life impact, psychological, social, outcome * Adverse effects : on the nose, on the forehead, eyebrows and scalp * Nasal Obstruction Symptom Evaluation (NOSE) * Short-Form-36 (SF 36) | Other | Operated patients |
| ControlResponse to the Nasal Reconstruction FACE-Q questionnaire, which includes the following scales : * Appearence : Face overall, nose, nostrils, skin impact psychological, impact social, * SF36 | Other | Control |
Primary outcome
Psychometric validation of the French version of Nasal Reconstruction FACE-Q
Time frame: 7 days
Test the acceptability, reliability, construct validity, and sensitivity to change of the questionnaire.
1 secondary outcome
Assessment of the post operative functional satisfaction
Time frame: 7 days
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 9 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 study director
Hôpital NOVO
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 Carcinoma, run by Hôpital NOVO 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 9 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 9 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychometric validation of the French version of Nasal Reconstruction FACE-Q (time frame: 7 days). 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 9 Jul 2026.