NCT07257094

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
346

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Jan 2026

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Jan 2026Jul 2027

First Submitted

Initial submission to the registry

November 21, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 10, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2027

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

1.6 years

First QC Date

November 21, 2025

Last Update Submit

March 26, 2026

Conditions

Carcinoma

Keywords

Basal Cell carcinomaSquamous Cell carcinomaRhinectomyReconstructive Surgical ProceduresProsthesis ImplantationFACE-QQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Psychometric validation of the French version of Nasal Reconstruction FACE-Q

    Test the acceptability, reliability, construct validity, and sensitivity to change of the questionnaire.

    7 days

Secondary Outcomes (1)

  • Assessment of the post operative functional satisfaction

    7 days

Study Arms (2)

Operated patients

Patients with skin cancer in the nasal region who have undergone surgical reconstruction using a flap or rehabilitation using a prosthesis.

Other: operated patients

Control

Patients with no history of surgery or facial trauma

Other: Control

Interventions

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)

Operated patients
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

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients / Controls

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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:
  • 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).
  • Non-English speaking subject
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

CHU Caen

Caen, 14000, France

NOT YET RECRUITING

Centre Antoine Lacassagne

Nice, 06000, France

RECRUITING

Institut Curie

Paris, 75005, France

NOT YET RECRUITING

Hôpital Lariboisière (AP-HP)

Paris, 75010, France

NOT YET RECRUITING

Hôpital Bichat (APHP)

Paris, 75018, France

NOT YET RECRUITING

Hopital Novo

Pontoise, 95300, France

RECRUITING

HNIA Toulon

Toulon, 83000, France

RECRUITING

CHU Toulouse

Toulouse, 31400, France

NOT YET RECRUITING

Institut Gustave Roussy

Villejuif, 94800, France

NOT YET RECRUITING

MeSH Terms

Conditions

CarcinomaCarcinoma, Basal CellCarcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal CellNeoplasms, Squamous Cell

Study Officials

  • Khaled AL TABAA, Doctor

    Hôpital NOVO

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2025

First Posted

December 2, 2025

Study Start

January 10, 2026

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

July 30, 2027

Last Updated

March 31, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(9)