Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT07257094
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nasal Reconstruction FACE-Q : French Validation of the Nasal Reconstruction FACE-Q Questionnaire for Reconstruction/Rehabilitation Following Nasal Skin Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 346}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2025-11-21', 'studyFirstSubmitQcDate': '2025-11-21', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychometric validation of the French version of Nasal Reconstruction FACE-Q', 'timeFrame': '7 days', 'description': 'Test the acceptability, reliability, construct validity, and sensitivity to change of the questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Assessment of the post operative functional satisfaction', 'timeFrame': '7 days', 'description': 'Evaluation of postoperative functional satisfaction using the NOSE questionnaire, which measures the severity of nasal breathing obstruction. Correlations will then be calculated between the NOSE score and each of the FACE-Q scales.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Basal Cell carcinoma', 'Squamous Cell carcinoma', 'Rhinectomy', 'Reconstructive Surgical Procedures', 'Prosthesis Implantation', 'FACE-Q', 'Quality of Life'], 'conditions': ['Carcinoma']}, 'descriptionModule': {'briefSummary': '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.\n\nWe 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.', 'detailedDescription': "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.\n\nFACE-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, it was developed and validated in English and requires cultural and linguistic adaptation for reliable use in French-speaking populations.\n\nThis 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients / Controls', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPATIENTS 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\n\nCONTROL Age ≥ 65 years Subject informed and not opposed to participating in the study\n\nSubject who has never undergone facial trauma or surgery, and without major comorbidity, defined as follows:\n\n* No heart failure (moderate or severe heart failure, history of heart attack within the last 6 months);\n* No severe chronic respiratory disease (no stage III-IV COPD, no prolonged oxygen therapy);\n* No uncontrolled diabetes or associated severe complications;\n* No active immunosuppressive diseases or high-dose immunosuppressive treatment;\n* No unstable or severe facial dermatological conditions;\n* No comorbidities seriously affecting quality of life or respiratory function (at the investigator's discretion).\n\nTranslated with DeepL.com (free version)\n\nExclusion Criteria:\n\nPATIENTS\n\n* Patient under anticoagulant or antiplatelet therapy\n* Non-French-speaking patient\n* Patient under legal protection (e.g., guardianship, legal safeguard) or with limited legal capacity\n* 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)\n* Pregnant or breastfeeding woman\n\nCONTROL\n\n* Non-English speaking subject\n* Subject under guardianship or legal protection, legally incompetent or with limited legal capacity\n* 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)\n* Pregnant or breastfeeding women"}, 'identificationModule': {'nctId': 'NCT07257094', 'briefTitle': 'Nasal Reconstruction FACE-Q : French Validation of the Nasal Reconstruction FACE-Q Questionnaire for Reconstruction/Rehabilitation Following Nasal Skin Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital NOVO'}, 'officialTitle': 'French Validation of the Nasal Reconstruction FACE-Q Questionnaire for Reconstruction/Rehabilitation Following Nasal Skin Cancer', 'orgStudyIdInfo': {'id': '2025-A02195-44'}, 'secondaryIdInfos': [{'id': 'CHRD 1424', 'type': 'OTHER', 'domain': 'HOPITAL NOVO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'operated patients', 'description': 'patients with skin cancer in the nasal region who have undergone surgical reconstruction using a flap or rehabilitation using a prosthesis.', 'interventionNames': ['Other: operated patients']}, {'label': 'Control', 'description': 'Patients with no history of surgery or facial trauma', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'operated patients', 'type': 'OTHER', 'description': 'Response to the Nasal Reconstruction FACE-Q questionnaire, which includes the following scales :\n\n* Appearence : Face overall, nose, nostrils, skin\n* Health related quality of life (HRQOL) : Early life impact, psychological, social, outcome\n* Adverse effects : on the nose, on the forehead, eyebrows and scalp\n* NOSE\n* SF36', 'armGroupLabels': ['operated patients']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Response to the Nasal Reconstruction FACE-Q questionnaire, which includes the following scales :\n\n* Appearence : Face overall, nose, nostrils, skin impact psychological, impact social,\n* SF36', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'country': 'France', 'contacts': [{'name': 'Maxime HUMBERT, Dr', 'role': 'CONTACT', 'email': 'humbert-m@chu-caen.fr', 'phone': '2 31 06 39 46'}], 'facility': 'CHU Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '06000', 'city': 'Nice', 'country': 'France', 'contacts': [{'name': 'Gilles POISSONNET, Doctor', 'role': 'CONTACT', 'email': 'gilles.poissonnet@nice.unicancer.fr', 'phone': '+33 4 92 03 14 38'}], 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75005', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Maria LESNIK, Doctor', 'role': 'CONTACT', 'email': 'maria.lesnik@curie.fr', 'phone': '01 44 32 45 35'}], 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Benjamin VERILLAUD, Pr', 'role': 'CONTACT', 'email': 'benjamin.verillaud@aphp.fr', 'phone': '01 42 49 80 68'}], 'facility': 'Hôpital Lariboisière (AP-HP)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75018', 'city': 'Paris', 'country': 'France', 'contacts': [{'name': 'Caroline HALIMI LEVY, Doctor', 'role': 'CONTACT', 'email': 'caroline.halimi@aphp.fr', 'phone': '+33 1 40 25 70 44'}], 'facility': 'Hôpital Bichat (APHP)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '95300', 'city': 'Pontoise', 'country': 'France', 'contacts': [{'name': 'Khaled AL TABAA, Doctor', 'role': 'CONTACT', 'email': 'khaled.altabaa@ght-novo.fr', 'phone': '+33 1 30 75 40 40', 'phoneExt': 'poste 71 51)'}], 'facility': 'Hopital Novo', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}, {'zip': '83000', 'city': 'Toulon', 'country': 'France', 'contacts': [{'name': 'Jean-Baptiste MORVAN, Pr', 'role': 'CONTACT', 'email': 'jean-baptiste.morvan@sainteanne.org', 'phone': '+33 4 83 16 25 86'}], 'facility': 'HNIA Toulon', 'geoPoint': {'lat': 43.12442, 'lon': 5.92836}}, {'zip': '31400', 'city': 'Toulouse', 'country': 'France', 'contacts': [{'name': 'Guillaume DE BONNECAZE, Pr', 'role': 'CONTACT', 'email': 'debonnecaze.g@chu-toulouse.fr', 'phone': '05 67 77 17 88'}], 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '94800', 'city': 'Villejuif', 'country': 'France', 'contacts': [{'name': 'Nadia BENMOUSSAREBIBO, Doctor', 'role': 'CONTACT', 'email': 'Nadia.BENMOUSSA-REBIBO@gustaveroussy.fr', 'phone': '01 42 11 46 03'}], 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Khaled AL TABAA, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hôpital NOVO'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital NOVO', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}