Ignite Creation Date:
2025-12-24 @ 2:19 PM
Ignite Modification Date:
2026-02-26 @ 2:15 AM
Study NCT ID:
NCT02875795
Status:
COMPLETED
Last Update Posted:
2020-07-29
First Post:
2016-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carcinologic Speech Severity Index
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-28', 'studyFirstSubmitDate': '2016-08-18', 'studyFirstSubmitQcDate': '2016-08-22', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'carcinologic speech severity index', 'timeFrame': 'day 0', 'description': 'The main objective is to demonstrate that the carcinologic speech severity index (C2SI), obtained by an automatic speech processing tool, produces equivalent or superior outcomes than a score of speech intelligibility obtained by human listeners, in terms of quality of life foreseeing the speech handicap, after the treatment of oral and/or pharyngeal cancer.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['linguistic', 'quality of life'], 'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'references': [{'pmid': '31178430', 'type': 'RESULT', 'citation': 'Balaguer M, Boisguerin A, Galtier A, Gaillard N, Puech M, Woisard V. Assessment of impairment of intelligibility and of speech signal after oral cavity and oropharynx cancer. Eur Ann Otorhinolaryngol Head Neck Dis. 2019 Oct;136(5):355-359. doi: 10.1016/j.anorl.2019.05.012. Epub 2019 Jun 6.'}]}, 'descriptionModule': {'briefSummary': 'The hypothesis of the present study is that an automatic assessment technic can measure the impact of the speech disorders on the communication abilities giving a severity index of speech in patients treated for head and neck and particularly for oral and pharyngeal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Oral and Pharyngeal cancer T2 to T4 for having a wide dynamic of deficit\n* Treatment by surgery and/or radiotherapy and/or chemotherapy\n* Delay after the end of the treatment of minimum 6 months.\n\nExclusion Criteria:\n\n* Patients with a previous speech disorders (ie stuttering… )\n* Patients not able to perform the whole task'}, 'identificationModule': {'nctId': 'NCT02875795', 'acronym': 'C2SI', 'briefTitle': 'Carcinologic Speech Severity Index', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'A Speech Disorders Severity Index to Measure the Impact of Oral and Pharyngeal Cavity on Speech Production', 'orgStudyIdInfo': {'id': '14 7414 07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'speech intelligibility', 'description': 'speech intelligibility is registered by an automatic speech processing tool', 'interventionNames': ['Procedure: automatic speech processing tool']}], 'interventions': [{'name': 'automatic speech processing tool', 'type': 'PROCEDURE', 'armGroupLabels': ['speech intelligibility']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Virginie WOISARD, Md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'woisard.v@chu-toulouse.fr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Jean-Jaures, Toulouse, France', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}