Head and Neck CancerC2SINCT02875795
Carcinologic Speech Severity Index
A study testing automatic speech processing tool in people with Head and Neck Cancer, run by University Hospital, Toulouse.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- automatic speech processing tool
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with a previous speech disorders (ie stuttering… )
- Patients not able to perform the whole task
About this study
Official title: A Speech Disorders Severity Index to Measure the Impact of Oral and Pharyngeal Cavity on Speech Production
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.
- Conditions
- Head and Neck Cancer
- Being tested
- automatic speech processing tool
- Keywords
- linguistic, quality of life
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
automatic speech processing toolProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| speech intelligibility | Experimental | speech intelligibility is registered by an automatic speech processing tool Receives: Procedure: automatic speech processing tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
carcinologic speech severity index
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.
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study start1 Jan 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- University Jean-Jaures, Toulouse, France
- Responsible party
- Sponsor
- Investigators
- Virginie WOISARD, Md, Principal investigator, woisard.v@chu-toulouse.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875795
- Sponsor's protocol ID
- 14 7414 07
- Acronym
- C2SI
- Status last verified
- Jul 2020
- First submitted
- 18 Aug 2016
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31178430
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Speech Disorders Severity Index to Measure the Impact of Oral and Pharyngeal Cavity on Speech Production
- ClinicalTrials.gov ID
- NCT02875795
- Acronym / sponsor ID
- C2SI / 14 7414 07
- Conditions
- Head and Neck Cancer
- Keywords
- linguistic, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- University Jean-Jaures, Toulouse, France
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| speech intelligibility | Experimental | Procedure: automatic speech processing toolspeech intelligibility is registered by an automatic speech processing tool |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with a previous speech disorders (ie stuttering… )
- Patients not able to perform the whole task
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| automatic speech processing tool | Procedure or surgery | speech intelligibility |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Results publication: PubMed 31178430Balaguer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginie WOISARD, Md principal investigator
woisard.v@chu-toulouse.fr
Questions about this trial
What is this clinical trial studying?
A study testing automatic speech processing tool in people with Head and Neck Cancer, run by University Hospital, Toulouse.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
carcinologic speech severity index (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02875795, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2020.