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Carcinologic Speech Severity Index (C2SI)

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ClinicalTrials.gov Identifier: NCT02875795
Recruitment Status : Completed
First Posted : August 23, 2016
Last Update Posted : July 29, 2020
Sponsor:
Collaborator:
University Jean-Jaures, Toulouse, France
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Head and Neck Cancer Procedure: automatic speech processing tool Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Speech Disorders Severity Index to Measure the Impact of Oral and Pharyngeal Cavity on Speech Production
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: speech intelligibility
speech intelligibility is registered by an automatic speech processing tool
 Procedure: automatic speech processing tool


Outcome Measures
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Primary Outcome Measures :
  1. carcinologic speech severity index [ Time Frame: day 0 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Oral and Pharyngeal cancer T2 to T4 for having a wide dynamic of deficit
  • Treatment by surgery and/or radiotherapy and/or chemotherapy
  • Delay after the end of the treatment of minimum 6 months.

Exclusion Criteria:

  • Patients with a previous speech disorders (ie stuttering… )
  • Patients not able to perform the whole task
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02875795


Sponsors and Collaborators
University Hospital, Toulouse
University Jean-Jaures, Toulouse, France
Investigators
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Principal Investigator: Virginie WOISARD, Md woisard.v@chu-toulouse.fr
More Information
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Publications of Results:

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02875795    
Other Study ID Numbers: 14 7414 07
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Toulouse:
linguistic
quality of life
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Neoplasms