Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT04447456
Status:
COMPLETED
Last Update Posted:
2023-02-06
First Post:
2020-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Voice Results at 5 Years of Treatment of Glottic Squamous Cell Carcinoma T1 by Surgery Versus Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-03', 'studyFirstSubmitDate': '2020-06-22', 'studyFirstSubmitQcDate': '2020-06-22', 'lastUpdatePostDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Voice Handicap Index', 'timeFrame': 'At 5 years', 'description': 'The VHI is a self-administered questionnaire that provides a score ranging from 0 to 120 points validated in France and internationally based on the declarative answers to 30 items of the questionnaire. A high score corresponds to a voice felt to be of poor quality. This is a subjective assessment made by the patient.'}], 'secondaryOutcomes': [{'measure': 'Maximum Phonation Time', 'timeFrame': 'At 5 years', 'description': 'The TMP is the measurement in seconds of a vowel (/a/) held for as long as possible.'}, {'measure': 'Grade, Roughness, Breathiness, Asthenia, Strain, Instability SCORE (GRBASI Score)', 'timeFrame': 'At 5 years', 'description': 'This score is obtained from an internationally and nationally validated hetero-assessment. It consists in the attribution by a listening jury made up of two people of a mark ranging from 0 to 3 for each of the 6 items: Grade, Roughness, Breathiness, Asthenia, Strain, Instability.\n\nA high score is associated with a voice perceived as bad by the audience.'}, {'measure': 'Acoustic Analysis by Vocalab software', 'timeFrame': 'At 5 years', 'description': "short recording of the patient's voice delivering a standardized speech on VOCALAB software validated by the scientific community."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Glottic Squamous Cell Carcinoma', 'Surgery', 'Radiotherapy', 'Voice'], 'conditions': ['Glottic Carcinoma']}, 'referencesModule': {'references': [{'pmid': '39122636', 'type': 'DERIVED', 'citation': 'Louison J, Labreuche J, Liem X, Rysman B, Morisse M, Mortuaire G, Mouawad F. Voice quality after surgery or radiotherapy for glottic T1 squamous cell carcinoma: Results of the VOQUAL study. Cancer Radiother. 2024 Aug;28(4):373-379. doi: 10.1016/j.canrad.2024.03.004. Epub 2024 Aug 9.'}]}, 'descriptionModule': {'briefSummary': 'Patients with early-stage squamous cell carcinomas of the vocal cord can be treated in an equivalent way in terms of carcinology by surgery or radiotherapy. The study will be to analyse the vocal outcome at 5 years of these two types of management in order to define whether one is superior to the other on this criterion of voice quality after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients treated for glottic squamous cell carcinoma at Lille University Hospital and the Oscar Lambret Centre between 2015 and 2017.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with glottic squamous cell carcinoma T1N0M0 who may benefit from treatment with exclusive radiotherapy or exclusive surgery.\n* patients treated for these cancers at Lille University Hospital and the Oscar Lambret Centre between 2015 and 2017.\n* Tis, T1a and T1b glottic squamous cell carcinomas according to the TNM 7th edition classification in long-term survivors.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT04447456', 'acronym': 'VO Qual', 'briefTitle': 'Comparison of Voice Results at 5 Years of Treatment of Glottic Squamous Cell Carcinoma T1 by Surgery Versus Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Comparison of Voice Results at 5 Years of Treatment of Glottic Squamous Cell Carcinoma T1 by Surgery Versus Radiotherapy', 'orgStudyIdInfo': {'id': '2019_68'}, 'secondaryIdInfos': [{'id': '2020-A00738-31', 'type': 'OTHER', 'domain': 'ID-RCB number,ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgery'}, {'label': 'Radiotherapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Lille', 'country': 'France', 'facility': 'Hôpital Huriez, CHU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'François Mouawad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}